[Hiring] Senior CAPA Engineer @Fresenius Medical Care

Role Description

Lead the harmonization and standardization of the product transfer process including execution and oversight of the product transfer process for assigned regional/global area.

• 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 (as appropriate) in the transfer of new products or site to site transfers between manufacturing sites.
• Ensure transfer projects comply with all quality and regulatory requirements, have clearly defined quality planning, including site registration, defined pfmea at receiving sites, training requirements established, inspections plans defined, validation plans developed and any other requirements as defined.
• Transfer reliable quality products into manufacturing through partnership with vertical value streams and manufacturing operations.
• Assist in establishing receiving site quality metrics for a successful product transfer (example; capability, complaint rates, all quality deliverables achieved).
• 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.
• Performs other related duties as assigned.
• Additional responsibilities may include focus on one or more departments or locations.

Qualifications

• Bachelor’s Degree; Advanced Degree desirable.

Requirements

• 6 – 8 years of relevant experience in Quality, Manufacturing and/or Engineering discipline.
• 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 - nice to have.

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 depending on company and individual performance.