Sr Principal Quality Engineer
Core
Senior technical leadership for quality engineering activities including product transfers, manufacturing process introductions, and process validation to ensure regulatory compliance and successful manufacturing transfer.
Role type
Senior Principal Quality Engineer (Product Transfer & Validation)
Builds
Robust, compliant, and scalable quality strategies for product and process transfers across the manufacturing network.
Domain
Life Sciences / Medical Devices / Manufacturing Validation
Required skills
Product transfer and validation quality engineering, pFMEA and process risk management, statistical process control and capability analysis, regulatory compliance (QMS), cross-functional stakeholder management, technical mentoring and coaching
Preferred skills
Advanced technical degree, experience in regulated environments, ability to operate independently
Technologies
pFMEA, CTQs, CQAs, MSA, validation protocols
Responsibilities
Lead development and execution of risk-based validation strategies for manufacturing processes and equipment; Provide senior quality engineering leadership for complex product transfers and technology introductions; Develop and drive quality strategies ensuring compliance with regulatory requirements; Mentor and coach quality engineers and junior personnel; Facilitate technical decision-making across multiple manufacturing sites and functions
Seniority
Principal, hands-on IC with strategic leadership