Senior Product Quality Engineer
Core
Provides design quality engineering guidance and support for New Product Introduction (NPI) and Product Life Cycle Management (LCM) for life science products, ensuring compliance with quality management systems and regulatory requirements.
Role type
Senior IC quality engineer (medical device/life science)
Builds
Design verification and validation documentation, risk management files, and quality control plans for electro-mechanical devices, software, hardware, and biocides.
Domain
Life sciences / Medical devices / Regulatory compliance
Required skills
Risk management (ISO 14971), Design Control, Design Verification and Validation, Root Cause Analysis, FMEA (DFMEA/SWFMEA), CAPA management, Statistical methodologies, 6-Sigma, Lean, Regulatory compliance (FDA QSR 21 CFR 820, ISO 13485)
Preferred skills
Software hazard analysis, IEC 62304, IEC 62366-1, IEC 60601 series, Requirements/test management tools (Jira/Xray/DOORS), Data analysis software
Technologies
Microsoft Excel, Word, PowerPoint, Jira, Xray, DOORS
Responsibilities
Own the Risk Management process and deliverables including hazard analysis and Risk Management File/Report; Manage the complaint-to-design-input pathway to translate field signals into design changes; Perform complex technical investigations including formal NCs and CAPAs; Support internal, external, and third-party audits as a Quality Subject Matter Expert; Provide training and guidance on quality management system elements to colleagues; Recommend improvements to quality systems using 6-Sigma and Lean methodologies.
Seniority
Senior, hands-on IC