• Manage quality projects, lead Continuous Improvement initiatives and, drive change to further integrate and implement Ivenix Infusion System into the Fresenius Kabi organization and systems.
• Provide quality leadership to product (design & sustaining) improvements.
• Support in any FDA remediation activities such as leading follow-up in case of FDA observations (483/Warning Letter), untitled letters, and other FDA questions.
• Stay updated of Field Corrective Actions, FAR/MDR-reporting and 483s of competitors.
• Prepare plants for and support during and if needed after FDA GMP or MDSAP-inspections.
• Participate in meetings with FDA and liaise with external service providers.
• Work closely with SMEs of the competence centers and closely collaborate with MedTech stakeholders.
• Participate in Expert Circles (ECs) and Corporate Emergency Committees (CECs) to provide input of U.S. regulations and FDA expectations regarding Field Corrective Action (FCA) decisions.
• Align with R&D on the direction for product risk management activities.
• Participate in the INS Change Control Board (CCB) and Product Review Process (PRM) to provide additional leadership and critical thinking in refining the post-market surveillance process and tying it into QMS procedures/integrate into global QMS.

Job Requirements

• Bachelor's Degree required, Master's preferred; in engineering
• 10 years of previous experience
• 5 years of experience in managing individuals.
• 5 years of experience with infusion pumps.
• Familiarity with electromechanical and software related medical devices.
• Experience with leading FDA remediation effort and understanding US FDA expectations.
• Demonstrated successful experience to drive change and lead projects.
• Strong written and oral communications.
• Willingness to travel.

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