Sr Design Quality Engineer (Mechanical/Electrical)
Core
Provides design quality engineering guidance and support for New Product Introduction (NPI) and Product Life Cycle Management (LCM) activities, ensuring compliance with Quality Management Systems and regulatory requirements for life science products.
Role type
Senior IC Quality Engineer (Regulatory/Medical Device)
Builds
Quality systems, risk management processes, and design control documentation for medical device products.
Domain
Life Sciences / Medical Devices / Regulatory Compliance
Deliverable
dashboards & analysis
Required skills
Risk Management, Design Control, Design Verification and Validation, Root Cause Analysis, FMEA, CAPA, FDA QSR 21 CFR 820, ISO13485, Statistical methodologies, 6-Sigma, Lean
Preferred skills
Method validation, microbiological method validation, cross-functional project leadership, audit interface experience
Technologies
Microsoft Excel, Word, PowerPoint
Responsibilities
Own the Risk Management process and facilitate risk analyses; Perform complex technical investigations including formal NCs and CAPAs; Provide training and guidance on quality management system elements; Identify and recommend improvements to quality systems using 6-Sigma and Lean; Participate in technical reviews and build cross-functional consensus; Support internal, external, and third-party audits as a Quality Subject Matter Expert; Interface with regulatory agencies or customers during audits.
Seniority
Senior, hands-on IC