Careers that make a difference! Freudenberg Medical designs and manufactures medical devices and components for clients worldwide.  We are focused on innovative processing technologies, lean manufacturing, waste reduction, and high quality product solutions for our Fortune 100 medical device customers.  Join our fast growing team with 11 manufacturing operations around the world. 

 

Ready to make a difference?

Supplier Quality Engineer I or II
Medical device quality system experience required in ISO13485 and ISO14971

Your tasks

  • Create and maintain quality records in accordance with FDA QSR and/or other regulatory requirements.
  • Create Q-sheets, Inspection Plans, and other component verification/validation documentation.  Facilitate the completion of component inspections and testing.
  • Initiate and lead the resolution of non-conformances / CAPAs.
  • Facilitate supplier quality issues, monitor supplier corrective actions and effectiveness, and ensure components are available to support builds.
  • Develop and implement validation protocols for new components and supplier changes.  Develop, maintain, execute, and control Component Validation Plans as needed.
  • Support the maintenance of risk management documentation (e.g. FMEAs, hazard analyses, risk assessments, etc.). 
  • Provide support to project teams in the compliance of ISO13485, MDD / MDR, QSR, JPAL, and any other applicable standards, requirements, or contracts.
  • Assist in the identification and selection of outside suppliers and consultants.
  • Ensure supplier quality documents are updated in the Document Management System.
  • Support the supplier and internal purchasing organizations with qualifications for process improvements and ongoing cost reductions.
  • Review supplier re-certification requirements and re-certify as needed.
  • Perform internal and supplier audits.
  • Support the component ship-to-stock and skip-lot programs.
  • Analyze test data using statistical tools, perform in-depth interpretation of results, and generate detailed technical reports.
  • Utilize Root Cause Analysis Tools in problem solving.
  • Create and maintain quality records for DHFs in accordance with FDA QSR and/or other regulatory requirements.
  • Perform other related duties as assigned, including supporting other groups within the Quality organization.
  • Represent FM MIS interests in communications with clients and suppliers.
  • Work collaboratively with engineers and other personnel that are assigned to product teams.
  • Share responsibility for meeting overall project deliverables and objectives.
  • Incorporate the Critical Chain Project Management (CCPM) Work Norms into your daily work habits.
  • Assist in the creation and maintenance of credible project schedules.

Our expectations

  • Bachelor of Science degree in Engineering or related field
  • 1 – 3+ years’ experience in quality engineering in the medical device industry.
  • Demonstrated competency in statistical process controls including control charts, data analysis, technical writing, continuous process improvement, including lean, six sigma, and validations.
  • 2 or more years of experience dealing with suppliers, supplier quality systems or quality system auditing.
  • Experience in a structured regulatory environment with advanced quality systems such as ISO 13485, FDA cGMP and MDR. CFR 21 820 with specialized knowledge of CFR 21 820.30 Design Controls and CFR 21 820.75 Process Validation, ISO 14971 Risk Management, and ISO 13485.
  • Quality Systems and auditing in accordance with ISO 13485 and ISO 9001.
  • Demonstrated experience with problem-solving methodologies and deductive skills.
  • Demonstrated experience with statistics, statistical problem solving, and DOE.
  • Accurate and attentive to detail.
  • Mechanical and problem solving skills; makes educated decisions based on data.
  • Communication and interpersonal skills to interact with engineers, other team members, outside suppliers, etc.
  • Ability to work independently as well as with others in a fast-paced, results-oriented environment.
  • Ability to manage multiple projects with conflicting priorities.
  • Strong unbiased advocate of compliance.
  • Communication skills: written, spoken and presentation.
  • Ability to travel, 10 to 20% of the time

 

Preferred Qualifications:

  • Certified Quality Engineer (CQE), Certified Quality Auditor (CQA) and/or, Certified Supply Chain Professional (CSCP)
  • Lean/Six Sigma certification

 

Freudenberg Medical, part of the Freudenberg Group, is a global partner for the design, development and manufacture of innovative medical devices and components. With 11 manufacturing operations and more than 1,500 associates worldwide, Freudenberg Medical offers a wide range of manufacturing capabilities from high precision molding and extrusion to drug coatings, finished devices, and subassemblies for catheters and minimally invasive devices.

For over 30 years, medical device and healthcare companies have trust Freudenberg Medical to manufacture their custom components and devices. We operate FDA-registered, ISO 13485 certified medical device facilities with Class 7 & 8 cleanrooms. Design and manufacturing operations are located in the United States (California, Indiana, Massachusetts, Minnesota), Germany, Ireland, Costa Rica, and China.

Freudenberg Medical manufactures minimally invasive, handheld and catheter-based devices out of our 93,000 square foot state-of-the-art facility, strategically and centrally located in Jeffersonville, Indiana. Freudenberg Medical’s culture is positive and team oriented. In our environment we like to have fun while helping others with our cutting edge medical devices. Our company is very driven to lead in the medical device industry to improve the quality of life of the patients we serve.

Freudenberg Medical is a local, innovative, high growth company with a collaborative, high performance work environment. We develop and manufacture minimally invasive, single use medical devices in the endoscopy, cardiovascular, neurovascular, and urology markets. The products we develop and manufacture are typically market disruptive and displace higher cost procedures.

 

Location: Louisville, KY (Facility in: Jeffersonville, IN)

 

It’s an exciting time to work at Freudenberg Medical. We know our ability to succeed depends upon the people we employ. Leading-edge technology, the highest standards, and outstanding people make Freudenberg Medical the employer of choice in this industry. We offer a competitive salary plus a full range of benefits including medical, dental and vision insurance, as well as 401K Match. #LI-FM2020

Do you have any questions?

Freudenberg Medical Minimally Invasive Solutions
Rachel Peterson ∙ Human Resources ∙ 2301 Centennial Blvd. ∙ 47130 Jeffersonville, IN ∙ www.freudenbergmedical.com/MIS
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