Senior CAPA Engineer

Fresenius Medical Care

. Lead harmonization and standardization of the product transfer process .

Posted 9/17/2026full-timeRemote • Florida • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in leading product transfer processes while ensuring compliance with quality and regulatory standards in the medical device and pharmaceutical industries. Proven ability to collaborate cross-functionally and implement continuous improvement initiatives.

Highest-signal resume keywords

Product Transfer Process ManagementQuality Assurance and ComplianceFDA and ISO 13485 KnowledgeCross-Functional CollaborationGMP Environment Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality PlanningValidation PlansPFMEAInspection PlansProcess StandardizationContinuous ImprovementDesign and Manufacturing ExperienceRegulatory ComplianceMetrics DevelopmentProject Management

Soft Skills

Excellent Communication SkillsCollaborationProblem-Solving

Industry Keywords

Medical DevicePharmaceuticalRegulated IndustryGMPFDA QSRsMDD/MDR Regulation

About the role

Key responsibilities & impact

Lead harmonization and standardization of the product transfer process
Execute and oversee product transfer processes for assigned regional/global areas
Develop, implement, and maintain Global Product Transfer processes for design and manufacturing product transfer
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 and site-to-site transfers
Ensure transfer projects comply with quality and regulatory requirements
Define quality planning, site registration, receiving-site 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
Oversee and execute policies and procedures to ensure consistent outcomes
Develop and execute quality and validation plans
Deliver procedural updates associated with adding new products at receiving manufacturing facilities
Ensure transfer activities comply with the quality system, FDA QSRs, and ISO 13485
Perform other related duties as assigned

Requirements

What you’ll need

Bachelor’s Degree
6–8 years of relevant experience in Quality, Manufacturing and/or Engineering discipline
Experience in medical device, pharma, or another regulated industry
Engineering background
Direct experience in design and/or manufacturing of medical devices/pharma in a GMP environment
Knowledge of FDA, MDD/MDR regulation in medical device and pharma
Proven track record in cross-functional collaboration
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
Approximately 30% travel

Benefits

Comp & perks

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