Sr CAPA Engineer

Fresenius Medical Care • Tampa, FL

7d

About The Position

The Sr CAPA Engineer leads the harmonization and standardization of the product transfer process, including execution and oversight for an assigned regional or global area. The role ensures that transferred products meet quality expectations at receiving manufacturing sites and comply with applicable quality systems and regulatory requirements. It works cross-functionally with quality, R&D, plant quality, manufacturing, and vertical value stream teams to transfer new products and products between manufacturing sites.

The position develops and maintains product transfer processes, quality and validation plans, and procedural updates for new products at receiving facilities. It establishes quality planning and metrics for successful transfers, including site registration, receiving-site PFMEAs, training, inspection plans, validation plans, capability, complaint rates, and completion of quality deliverables. The role also oversees transfer policies and procedures and ensures compliance with FDA QSRs and ISO 13485. Approximately 30% travel is required. The position has no supervisory responsibilities.

Requirements

• Bachelor’s degree.
• 6–8 years of relevant experience in a quality, manufacturing, and/or engineering discipline.
• Engineering background.
• Direct experience in the design and/or manufacturing of medical devices or pharmaceuticals in a GMP environment.
• Proven track record in cross-functional collaboration.
• Knowledge of FDA and MDD/MDR regulations in medical devices and pharmaceuticals.
• Excellent communication skills, including the ability to present and explain complex topics to multiple organizational levels.
• Demonstrated practice of continuous improvement and designing efficiency into processes.

Nice To Haves

• Advanced degree desirable.
• Automotive PPAP experience is a plus.
• Bilingual in Spanish.

Responsibilities

• Develop, implement, and maintain global product transfer processes for design and manufacturing transfers.
• Ensure product quality at receiving manufacturing sites during product transfer projects.
• Partner with CE vertical quality, R&D, plant quality, and manufacturing teams on new-product transfers and site-to-site transfers.
• Ensure transfer projects meet quality and regulatory requirements and include defined quality planning, site registration, receiving-site PFMEAs, training requirements, inspection plans, validation plans, and other applicable requirements.
• Transfer reliable quality products into manufacturing in partnership with vertical value streams and manufacturing operations.
• Assist in establishing receiving-site quality metrics for successful product transfers, such as capability, complaint rates, and completion of quality deliverables.
• Oversee and execute policies and procedures to ensure consistent outcomes.
• Develop and execute quality and validation plans.
• Deliver procedural updates associated with adding a new product at a receiving manufacturing facility.
• Ensure transfer activities comply with the quality system, FDA QSRs, and ISO 13485.
• Perform other related duties as assigned; additional responsibilities may focus on particular departments or locations.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• 401(k) with company match
• Paid time off
• Parental leave
• Potential for performance-based bonuses depending on company and individual performance

What This Job Offers

• Job Type: Full-time
• Career Level: Senior