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About the Role
Lead the harmonization and standardization of the product transfer process, including execution and oversight for assigned regional/global areas.
Responsibilities
- Develop, implement, and maintain Global Product Transfer processes for design and manufacturing product transfer.
- Ensure product quality is achieved at the receiving manufacturing site level during product transfer projects.
- Partner with CE vertical quality, R&D teams, plant quality and manufacturing teams in the transfer of new products or site to site transfers.
- Ensure transfer projects comply with all quality and regulatory requirements, including site registration, defined pfmea, training requirements, inspection plans, and validation plans.
- Transfer reliable quality products into manufacturing through partnership with vertical value streams and manufacturing operations.
- Assist in establishing receiving site quality metrics for successful product transfer.
- Oversee and execute policies and procedures to ensure consistent outcomes.
- Develop and execute quality and validation plans.
- Deliver all required procedural updates associated with the addition of a new product at the receiving manufacturing facility.
- Ensure all transfer activities are in compliance with the quality system, FDA QSRs and ISO 13485.
- Perform other related duties as assigned.
Requirements
- 6 – 8 years of relevant experience in Quality, Manufacturing and/or Engineering discipline.
- Experience in medical device, pharma or other regulated industry (automotive PPAP experience a plus).
- Engineering background.
- Direct experience in design and/or manufacturing of medical devices/pharma in a GMP environment.
- Proven track record in cross-functional collaboration.
- Knowledge of FDA, MDD/MDR regulation in medical device and pharma.
- Excellent communication skills with the ability to present and explain complex topics to multiple levels within the organization.
- Demonstrated practice of continuous improvement and designing efficiency into processes.
- Bilingual in Spanish is a plus.
Skills
- Product Transfer Process
- Quality Assurance
- Manufacturing Operations
- Regulatory Compliance
- FDA QSR
- ISO 13485
- GMP
- Cross-functional Collaboration
- Communication
- Continuous Improvement
Work Type
- 30% travel required
Experience Level
- 6-8 years relevant experience
Education Level
- Bachelor’s Degree
- Advanced Degree desirable
Benefits
- Comprehensive benefits package including medical, dental, and vision insurance.
- 401(k) with company match.
- Paid time off.
- Parental leave.
- Potential for performance-based bonuses.
About the Company
- Fresenius Medical Care maintains a drug-free workplace.
Equal Opportunity
- Fresenius Medical Care is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sexual orientation, gender identity, parental status, national origin, age, disability, military service, or other non-merit-based factors.