Job Summary

We currently have an opportunity for a Summer 2024 Intern in the Medical Device Division to join the Labeling team at our Lake Zurich, IL facility. The Labeling Intern role will support labeling related activities across the Labeling Team and across end-to-end labeling process(es) within the Fresenius- Kabi MedTech Transfusion and Cell Technologies (TCT) Division in accordance with global medical device regulations for medical devices, drugs, and combination products.

Responsibilities

Labeling Team scope includes development of strategy, creation, and management of global labeling requirements, specifications and released artwork for multiple types of manuals, instructions for use, package serts, release notes, product & package labeling in addition to Global UDI and Global electronic instructions for use (eIFU) activities.   Scope of team also includes the implementation and maintenance of labeling related platforms and tools and harmonizing legacy processes and practices across TCT and MedTech locations.  

Interns can expect to participate in global labeling requirements development, labeling & labeling component design (e.g. desktop publishing, technical illustrations),  technical writing, global UDI data / master data collection, eIFU publication, proofreading & editing of label content, translation / localization management across product portfolio for multiple types of labeling deliverables for a variety of medical devices used in blood centers, plasma centers, and hospitals.

Specific activities / projects may include, but are not limited to:

• Review / Revise / Create drawings, specifications, labels, and instructions for use
• Create Charts, Graphs, flow charts, spreadsheets, and / or forms for illustrative conents
• With guidance, run simulated procedures to improve usability of manuals for legacy devices
• With guidance, create / update consistent global labeling requirements (design inputs) for specific products – updating to current standards
• Support the data collection / data clean up of regulated product data for specific product codes for publication across applicable global UDI databases such as FDA GUDID, EU EUDAMED, Australia (New), Saudi Arabia, South Korea,
• Support the implementation and publication of eIFU for specific product lines, including preparing legacy labeling for “electronic portability/ electronic distribution readiness”
• Preparing reports, analytics, and analysis of labeling related metrics related to process / tool performance and identify potential areas for ongoing improvement efforts
• Other labeling team related activities as needed

Requirements

• Intern candidates must be permanently authorized to work in the U.S.
• Our internships are unable to accommodate OPT. 
• Interns are responsible for their own housing.
• Currently enrolled as a student at an accredited college
• Pursuing a degree program in any of the following disciplines; Engineering, Biology, Regulatory, Graphic Arts, Design, Medical Writing, Professional Writing or any other related field.
• Be classified as a minimum of a sophomore.
• Must be planning to return to school at the end of their break
• Design, Graphic Arts, and / or instructional design focus preferred.   
• Technical Writing / Professional writing skills.  
• Microsoft Office Suite, MS Illustrator, Visio, Adobe.
• Ability to distill complex process content to brief, concise, and understandable language and / or illustrations. 
• Curiosity and drive to see how innovative labeling strategies and solutions can bring complex global compliance, business, technical and human factors requirements together. 

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary

This position offers floor support to the Manufacturing Team. This is a position that requires a positive attitude and demonstrates a willingness to support teamwork. This position requires that the individual is flexible, adaptable and willing to move where needed to support the Manufacturing Floor.

*This 2nd shift position starts with training for 2-3 weeks Monday-Friday, 7:00 a.m.-3:30 p.m., and then after training is complete your schedule will be Monday-Friday, 3:00-11:30 p.m.

Responsibilities

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary

We currently have an opportunity for a Summer 2024 Intern in the Medical Device Division to join the Labeling team at our Lake Zurich, IL facility. The Labeling Intern role will support labeling related activities across the Labeling Team and across end-to-end labeling process(es) within the Fresenius- Kabi MedTech Transfusion and Cell Technologies (TCT) Division in accordance with global medical device regulations for medical devices, drugs, and combination products.

Responsibilities

Labeling Team scope includes development of strategy, creation, and management of global labeling requirements, specifications and released artwork for multiple types of manuals, instructions for use, package serts, release notes, product & package labeling in addition to Global UDI and Global electronic instructions for use (eIFU) activities.   Scope of team also includes the implementation and maintenance of labeling related platforms and tools and harmonizing legacy processes and practices across TCT and MedTech locations.  

Interns can expect to participate in global labeling requirements development, labeling & labeling component design (e.g. desktop publishing, technical illustrations),  technical writing, global UDI data / master data collection, eIFU publication, proofreading & editing of label content, translation / localization management across product portfolio for multiple types of labeling deliverables for a variety of medical devices used in blood centers, plasma centers, and hospitals.

Specific activities / projects may include, but are not limited to:

• Review / Revise / Create drawings, specifications, labels, and instructions for use
• Create Charts, Graphs, flow charts, spreadsheets, and / or forms for illustrative conents
• With guidance, run simulated procedures to improve usability of manuals for legacy devices
• With guidance, create / update consistent global labeling requirements (design inputs) for specific products – updating to current standards
• Support the data collection / data clean up of regulated product data for specific product codes for publication across applicable global UDI databases such as FDA GUDID, EU EUDAMED, Australia (New), Saudi Arabia, South Korea,
• Support the implementation and publication of eIFU for specific product lines, including preparing legacy labeling for “electronic portability/ electronic distribution readiness”
• Preparing reports, analytics, and analysis of labeling related metrics related to process / tool performance and identify potential areas for ongoing improvement efforts
• Other labeling team related activities as needed

Requirements

• Intern candidates must be permanently authorized to work in the U.S.
• Our internships are unable to accommodate OPT. 
• Interns are responsible for their own housing.
• Currently enrolled as a student at an accredited college
• Pursuing a degree program in any of the following disciplines; Engineering, Biology, Regulatory, Graphic Arts, Design, Medical Writing, Professional Writing or any other related field.
• Be classified as a minimum of a sophomore.
• Must be planning to return to school at the end of their break
• Design, Graphic Arts, and / or instructional design focus preferred.   
• Technical Writing / Professional writing skills.  
• Microsoft Office Suite, MS Illustrator, Visio, Adobe.
• Ability to distill complex process content to brief, concise, and understandable language and / or illustrations. 
• Curiosity and drive to see how innovative labeling strategies and solutions can bring complex global compliance, business, technical and human factors requirements together. 

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary

This position offers floor support to the Manufacturing Team. This is a position that requires a positive attitude and demonstrates a willingness to support teamwork. This position requires that the individual is flexible, adaptable and willing to move where needed to support the Manufacturing Floor.

*This position is Monday-Friday, generally 6:00 a.m.-2:30 p.m. or 7:00 a.m.-3:30 p.m.

Responsibilities

• Provide resources to assemble, test, and packaging support for various Medical Device Manufacturing Production Lines
• Perform basic electro-mechanical assembly and quality control inspections. These functions are to be performed in a timely manner to meet quality and productivity goals of the department.
• Utilize hand-held tools such as hand-held screwdrivers and electric torque drivers.
• Maintain appropriate inventory of material at assigned work station.
• Perform all work in accordance with quality standards and established procedures.
• Identify product defects and effectively document the defect when identified.
• Maintain a clean and safe work area.
• Perform all applicable work steps in accordance with good manufacturing practices.
• Document actions and products by completing required quality and production forms.

Job Requirements:

• High School Diploma/GED.
• Basic reading and writing skills.  Must be able to follow step-by-step directions.
• Basic computer navigation skills.
• Good attention to detail and ability to perform work accurately and thoroughly.
• Ability to identify material and information on parts.
• Adequate written and verbal communication skills.
• Physical requirements:
  • Regularly lift parts and components up to 30 pounds.
  • Regularly perform repetitive tasks.
  • Possess the manual dexterity necessary to put parts or assemblies together efficiently.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary

This position offers floor support to the Manufacturing Team. This is a position that requires the mastery of multiple workstations across the Fresenius Kabi Warrendale production floor. This position requires that the individual has prior applicable experience and demonstrates the capability to be a top performer on the manufacturing team.

*This position is Monday-Friday, generally 6:00 a.m.-2:30 p.m. or 7:00 a.m.-3:30 p.m

Responsibilities

• Demonstrates the ability to learn multiple work stations across various product lines at Fresenius Kabi Warrendale
• Can effectively communicate and provide feedback to engineers and technicians regarding device defects and documentation changes
• Demonstrates a high level of mechanical aptitude and performs all work with a high degree of accuracy
• Provides resources to assemble, test, and packaging support for various Medical Device Manufacturing Production Lines
• Provides a supporting role in the way of quality control.
• Performs basic to advanced electro-mechanical assembly and quality control inspections.
• Uses specialized manufacturing equipment and monitors equipment for maintenance/upkeep needs
• Maintain appropriate inventory of material at assigned work station
• Perform all work in accordance with quality standards and established procedures
• Quickly identifies product defects and effectively documents the defect when identified
• Perform all applicable work steps in accordance with good manufacturing practices
• Other duties as assigned.

• Job Requirements:

• 2+ years minimum of electro-mechanical assembly experience in Medical Device or related field
• Good reading and writing skills
• Ability to contribute as part of a team and train/teach other operators
• Strong computer navigation skills
• High attention to detail and ability to perform work accurately and thoroughly
• Demonstrated high performance orientation and detail orientation.
• Strong written and verbal communication skills.
• Demonstrates good organization and teamwork skills, including strong customer focus.
• Physical requirements:
  • Regularly lift parts and components up to 30 pounds
  • Regularly perform repetitive tasks
  • Possess the manual dexterity necessary to put parts or assemblies together efficiently

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary

This position offers floor support to the Manufacturing Team. This is a position that requires a positive attitude and demonstrates a willingness to support teamwork. This position requires that the individual is flexible, adaptable and willing to move where needed to support the Manufacturing Floor.

*This position is Monday-Friday, generally 6:00 a.m.-2:30 p.m. or 7:00 a.m.-3:30 p.m.

Responsibilities

• Provide resources to assemble, test, and packaging support for various Medical Device Manufacturing Production Lines
• Perform basic electro-mechanical assembly and quality control inspections. These functions are to be performed in a timely manner to meet quality and productivity goals of the department.
• Utilize hand-held tools such as hand-held screwdrivers and electric torque drivers.
• Maintain appropriate inventory of material at assigned work station.
• Perform all work in accordance with quality standards and established procedures.
• Identify product defects and effectively document the defect when identified.
• Maintain a clean and safe work area.
• Perform all applicable work steps in accordance with good manufacturing practices.
• Document actions and products by completing required quality and production forms.

Job Requirements:

• High School Diploma/GED.
• Basic reading and writing skills.  Must be able to follow step-by-step directions.
• Basic computer navigation skills.
• Good attention to detail and ability to perform work accurately and thoroughly.
• Ability to identify material and information on parts.
• Adequate written and verbal communication skills.
• Physical requirements:
  • Regularly lift parts and components up to 30 pounds.
  • Regularly perform repetitive tasks.
  • Possess the manual dexterity necessary to put parts or assemblies together efficiently.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary

This position offers floor support to the Manufacturing Team. This is a position that requires a positive attitude and demonstrates a willingness to support teamwork. This position requires that the individual is flexible, adaptable and willing to move where needed to support the Manufacturing Floor.

*This 2nd shift position starts with training for 2-3 weeks Monday-Friday, 7:00 a.m.-3:30 p.m., and then after training is complete your schedule will be Monday-Friday, 3:00-11:30 p.m.

Responsibilities

• Provide resources to assemble, test, and packaging support for various Medical Device Manufacturing Production Lines
• Perform basic electro-mechanical assembly and quality control inspections. These functions are to be performed in a timely manner to meet quality and productivity goals of the department.
• Utilize hand-held tools such as hand-held screwdrivers and electric torque drivers.
• Maintain appropriate inventory of material at assigned work station.
• Perform all work in accordance with quality standards and established procedures.
• Identify product defects and effectively document the defect when identified.
• Maintain a clean and safe work area.
• Perform all applicable work steps in accordance with good manufacturing practices.
• Document actions and products by completing required quality and production forms.

Job Requirements:

• High School Diploma/GED.
• Basic reading and writing skills.  Must be able to follow step-by-step directions.
• Basic computer navigation skills.
• Good attention to detail and ability to perform work accurately and thoroughly.
• Ability to identify material and information on parts.
• Adequate written and verbal communication skills.
• Physical requirements:
  • Regularly lift parts and components up to 30 pounds.
  • Regularly perform repetitive tasks.
  • Possess the manual dexterity necessary to put parts or assemblies together efficiently.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary

This position offers floor support to the Manufacturing Team. This is a position that requires a positive attitude and demonstrates a willingness to support teamwork. This position requires that the individual is flexible, adaptable and willing to move where needed to support the Manufacturing Floor.

*This position is Monday-Friday, generally 6:00 a.m.-2:30 p.m. or 7:00 a.m.-3:30 p.m.

Responsibilities

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary

This position offers floor support to the Manufacturing Team. This is a position that requires a positive attitude and demonstrates a willingness to support teamwork. This position requires that the individual is flexible, adaptable and willing to move where needed to support the Manufacturing Floor.

*This position is Monday-Friday, generally 6:00 a.m.-2:30 p.m. or 7:00 a.m.-3:30 p.m.

Responsibilities

• Provide resources to assemble, test, and packaging support for various Medical Device Manufacturing Production Lines
• Perform basic electro-mechanical assembly and quality control inspections. These functions are to be performed in a timely manner to meet quality and productivity goals of the department.
• Utilize hand-held tools such as hand-held screwdrivers and electric torque drivers.
• Maintain appropriate inventory of material at assigned work station.
• Perform all work in accordance with quality standards and established procedures.
• Identify product defects and effectively document the defect when identified.
• Maintain a clean and safe work area.
• Perform all applicable work steps in accordance with good manufacturing practices.
• Document actions and products by completing required quality and production forms.

Job Requirements:

• High School Diploma/GED.
• Basic reading and writing skills.  Must be able to follow step-by-step directions.
• Basic computer navigation skills.
• Good attention to detail and ability to perform work accurately and thoroughly.
• Ability to identify material and information on parts.
• Adequate written and verbal communication skills.
• Physical requirements:
  • Regularly lift parts and components up to 30 pounds.
  • Regularly perform repetitive tasks.
  • Possess the manual dexterity necessary to put parts or assemblies together efficiently.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary

This position offers floor support to the Manufacturing Team. This is a position that requires a positive attitude and demonstrates a willingness to support teamwork. This position requires that the individual is flexible, adaptable and willing to move where needed to support the Manufacturing Floor.

*This 2nd shift position starts with training for 2-3 weeks Monday-Friday, 7:00 a.m.-3:30 p.m., and then after training is complete your schedule will be Monday-Friday, 3:00-11:30 p.m.

Responsibilities

• Provide resources to assemble, test, and packaging support for various Medical Device Manufacturing Production Lines
• Perform basic electro-mechanical assembly and quality control inspections. These functions are to be performed in a timely manner to meet quality and productivity goals of the department.
• Utilize hand-held tools such as hand-held screwdrivers and electric torque drivers.
• Maintain appropriate inventory of material at assigned work station.
• Perform all work in accordance with quality standards and established procedures.
• Identify product defects and effectively document the defect when identified.
• Maintain a clean and safe work area.
• Perform all applicable work steps in accordance with good manufacturing practices.
• Document actions and products by completing required quality and production forms.

Job Requirements:

• High School Diploma/GED.
• Basic reading and writing skills.  Must be able to follow step-by-step directions.
• Basic computer navigation skills.
• Good attention to detail and ability to perform work accurately and thoroughly.
• Ability to identify material and information on parts.
• Adequate written and verbal communication skills.
• Physical requirements:
  • Regularly lift parts and components up to 30 pounds.
  • Regularly perform repetitive tasks.
  • Possess the manual dexterity necessary to put parts or assemblies together efficiently.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary

The Machinist II will be part of the manufacturing team and will work with Lead Machinist on the production of machined components. Their primary function will be setting up and operating machine equipment to produce components according to engineering prints.

*This 3rd shift position starts with training for 2-3 weeks Monday-Friday, 7:00 a.m.-3:30 p.m., and then after training is complete your schedule will be Monday-Friday, 11:00 p.m.-7:30 a.m.

Responsibilities

• Review samples, drawings or instructions to understand specifications of output
• Set up fixturing and tooling, for CNC lathe, mill, or mill-turn
• Measure, examine, or test completed units to check for defects and ensure conformance to specifications, using precision instruments.
• Plan the sequence of necessary actions for the completion of a job
• Monitor machine while working to adjust the feed, maintain temperature and identify issues
• Monitor output to ensure consistency with specifications and discard defects
• Perform routine machine maintenance
• Dispose of scrap or waste material in accordance with company policies and environmental regulations.
• Operate multi-axis machining centers (5 axis mills, lathes, mill-turn, etc.) in an efficient manner
• Troubleshoot issues, adjust programming to compensate for tooling wear, perform in-process measurements
• Perform quality control, follow reporting and recordkeeping procedures, and report problems to supervisor
• Comply with all safety and health regulations
• Clean machinery and maintain cleanliness in work area

Job requirements:

• High school diploma/GED.
• Formal education in machining from an accredited institution strongly preferred.
• Experience or knowledge of setups, basic maintenance, editing of programs on CNC equipment.
• Ability to read and interpret schematics, blueprints, and drawings.
• Experience with Mazatrol preferred.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary

The Machinist I will set up, operate, and maintain equipment for use in a machine shop production environment. They are responsible for ensuring the machinery produces high quality metal parts, runs smoothly and at capacity, and is properly maintained. This position is intended for a machine shop and/or a post-processing (chemical treatment and painting) environment.

*This 3rd shift position starts with training for 2-3 weeks Monday-Friday, 7:00 a.m.-3:30 p.m., and then after training is complete your schedule will be Monday-Friday, 11:00 p.m.-7:30 a.m.

Responsibilities

• Start equipment and make adjustments to equipment when necessary to improve performance
• Operate machinery and equipment according to instructions
• Troubleshoot issues and perform maintenance
• Perform quality control, follow reporting and recordkeeping procedures, and report problems to supervisor
• Comply with all safety and health regulations
• Clean machinery and maintain cleanliness in work area
• Other tasks as assigned by Supervisor

Job requirements:

• High school diploma/GED
• Ability to read and interpret schematics, blueprints, and drawings.
• Proven sound judgment, values driven, continuous innovation and improvement and adaptability skills.
• Strong mechanical aptitude
• Demonstrated high performance orientation and detail orientation.
• Strong written and verbal communication skills.
• Good organization and teamwork skills, including strong customer focus.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary

The Senior Post Market Quality Assurance Associate processes complaints to ensure timely and accurate evaluation and completion of customer complaints. May back up the US Vigilance Team with submissions of Field Alert Reports (FAR) and Medical Device Reports (MDR) as required to comply with all regulatory obligations. Creates reports used for Key Process Indicators (KPI) and aids in the processing of complaints.

*This position requires working onsite 3 days per week at our Lake Zurich, IL site, and remaining days may be worked remotely.

Responsibilities

• Process, analyze, and escalate customer complaints, collecting required information as indicated per internal Standard Operating Procedures (SOPs) and Food and Drug Administration (FDA) regulations.
• Collaborate with local Quality Engineers and manufacturing facilities to assess customer complaints and identify issues that could potentially be reportable.  Escalate complaints that are potentially Medical Device Reportable (MDR) to the National Safety Officer (NSO) and Corporate Safety Officer (CSO).  Escalate potential Adverse Drug Event (ADE) or Field Alert Reports (FAR) to the Manufacturing plant for evaluation.
• If required, report ADE, MDR and FARs to the FDA. This includes tracking, follow up and closure activities of each event and as back up to the US Vigilance Team.
• Ensure investigations conform to the requirements set forth in the global and local SOP’s and in accordance with FDA regulations.
• Collaborate with Quality Engineers and Quality Associates on trends and complaint investigation activities as needed.
• As required, work with external suppliers and supplier quality personnel on investigation activities associated with complaints related to purchased products. 
• Responsible for setting individual work schedule to ensure complaint processing and follow up activities are within the timing guidelines listed in the global SOP for complaint handling.
• Perform trend reporting, provide KPIs and ad hoc reporting based on management requirements.  
• Create, update and maintain Post Market Quality Assurance (PMQA) Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• Conduct training to complaint handling personnel as needed, to further enhance skills, understanding of product use, and help identify incidents that may lead to reportable events.

Job Requirements

• Bachelor’s degree preferred or equivalent work experience.
• 5+ years of related work experience
• Knowledge of FDA Quality Systems and Medical Device Reporting regulations (21 CFR 803, 820 & 211; Part 11) plus ISO 13485/MDSAP, ISO 9001, and EU MDR required.
• Strong computer skills (e.g., Word, PowerPoint, Excel)
• SAP experience is strongly preferred.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary

The Clinical Education Consultant provides customers with clinical, functional, and operational expertise in the following areas: educational and systems development consulting, product line utilization management and services, and clinical sales-related support to the Account Executives and Sales Management. Conducts product training for customers during the initial and ongoing sales process. Provides clinical support and analysis for program implementations and product utilization as requested.

The territory for this position includes Northern California, Idaho, Oregon, Washington, Utah, Montana, Idaho, Alaska, North Dakota and South Dakota. The selected candidate must live near a major airport.

The ideal candidate will live in Seattle, Washington or Portland, Oregon.

Responsibilities

• Collaborate with Account Executive (AE) to determine potential sales opportunities and provide clinical support during the sales process, helping to accomplish sales objectives and build customer relationships.  
• Support implementation initiatives at customer site delivering product training, on-going analysis, and support for use, upgrades, and enhancements.
• Prepare territory business plans and contribute to AE/Manager-led business reviews with executive-level customers.
• Implement consulting strategies as dictated by the needs of the marketplace and company, collaborating with account team and management. May assist determining potential sales opportunities and how to accomplish sales objectives in blood centers, hospitals, and large national accounts, as it relates to clinical education and consulting services.  

Facilitate supply utilization, standardization, and optimization through the following activities:  

• Developing technical solutions to problems within the operations of the customers’ environment
• Data collection, interpretation, and analysis
• Problem-solving and consensus-building   
• Build an understanding of the customers’ business needs, SOPs, validation requirements, documentation needs, and any regulatory industry guidelines.   
• Ability to identify sales growth and customer-focused, value opportunities within existing customer base.
• Provide customer feedback and act as a consultant to Sales, Marketing and R&D teams on designing new and improving existing products and customer utilization needs.  
• Keep current on trends and regulations in the blood banking industry through self-directed attendance at meetings, seminars, and current reading of professional journals.
• Maintain product competency and keep current on product-related training, use, enhancements, and changes.
• Regular collaboration with Learning and Development, including support of document development, review, and materials needed for customer training and commercial business needs.
• Consistently provide updates on customer-facing activities and maintain account data profiles in CRM.
• Provide timely communication to customers and maintain accurate records of customer interactions.
• Manage budget and expenses, adhere to company policies. 
• All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities.

Requirements

• 3-5 years’ experience in a clinical lab/environment, component manufacturing and leukoreduction processing a plus.  
• Registered Nurse, Licensed Vocation Nurse, or Med Tech preferred.
• Demonstrated skills in providing solutions, problem solving and decision-making.
• Strong verbal/written communication skills.
• Advanced Microsoft Office skills demonstrating use and proficiency.
• Ability to adapt to changing customer, industry, and business needs.
• Customer service skills with experience in relationship/team building.
• Strong territory management with ability to balance customer & business needs. 
• Experience developing SOPs, validation plans and implementing medical devices preferred.
• Strong presentation and facilitation skills in a live or virtual setting.
• Technical troubleshooting experience. 
• Previous training experience.
• 60% travel.
• No relocation assistance available. 
   

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary

The Plasma Services Consultant is responsible for providing technical and operator l product and sales support for customer organizations within an assigned territory in US. Act as key customer liaison and consultant managing both customer and company needs. Assist in process and operational improvements within a customer center and ensures that customers are properly trained in the use of our products and the repair of instrumentation.

This position will cover the Northeast/New England part of the United States. The ideal candidate will live in one of the following states: New York, Massachusetts, Pennsylvania, Maryland, Delaware, Virginia, New Jersey or Rhode Island

Responsibilities

• Management of customer accounts within an assigned territory.
• Utilize consulting and DMAIC principles to support customer operations and efficiencies.
• Provide on-call consulting and troubleshooting services on the Plasma Support line.
• Provide product and technical leadership as well as sales support for customers within an assigned territory.
• Train customers in the proper use of Fresenius Kabi products.
• Conduct training classes for instrument operators; and perform periodic assessments and re-trainings as     necessary.
• Conduct technical training to self-service customer in a classroom setting.
• Work with sales and marketing to develop and launch new products and drive product acceptance and sales within assigned customer base.
• Work one-on-one with customers in the field to support their troubleshooting and mechanical skills.
• Assist the Account Management consultants in managing national account responsibilities.
• Provide input regarding product and services offerings to assure they are viewed as value added to our customers.
• Act as a consultant to the plasma center managers by helping to show best demonstrated practices within the industry
• Installation of plasmapheresis devices and support of new customers; can be greater than 20% of functional role.
• All employees are responsible for ensuring the compliance to company documents, programs and activities    related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities

Requirements

• Bachelor’s degree preferred.
•  A minimum of 3 years’ Experience working in a leadership position in Biologics or Plasma.
• Strong written and verbal communication skills.
• Effectively able to utilize Microsoft applications (Word, Excel, One Drive).
• Ability to travel extensively, greater than 75%.
• Ability to lift 60 lbs.
• Ability to stand for long periods of time.
• Ability to balance multiple projects at the same time.
• Ability to troubleshoot and problem-solve electrical instrumentation.
• Ability to educate others.
• Overall knowledge and understanding of the Plasma and Blood Bank industries.
• Overall knowledge of the Regulatory and Quality environment in the Plasma and Blood Bank industries.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.