Sr CAPA Engineer
Core
Lead harmonization and standardization of the product transfer process for design and manufacturing, ensuring quality compliance at receiving sites.
Role type
Senior CAPA Engineer (Quality/Manufacturing)
Builds
Global Product Transfer processes for medical devices/pharma
Domain
Medical device / Pharma / Regulated manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Product transfer process design, GMP environment experience, FDA QSRs and ISO 13485 compliance, Quality planning (PFMEA, validation plans), Cross-functional collaboration, Continuous improvement, Engineering background
Preferred skills
Automotive PPAP experience, Bilingual Spanish
Technologies
None stated
Responsibilities
Develop and maintain Global Product Transfer processes, Ensure product quality at receiving sites, Partner with quality and manufacturing teams, Execute quality and validation plans, Establish receiving site quality metrics, Oversee policies for consistent outcomes, Deliver procedural updates for new products
Seniority
Senior, hands-on IC