Senior Engineer, Quality Engineering
Core
Ensure quality, safety, and regulatory compliance of medical product portfolio through strategic MQMS improvements and lifecycle oversight.
Role type
Senior Medical Quality Engineer (Regulatory & Systems)
Builds
Medical device quality management systems and regulatory documentation
Domain
Medical Devices / Healthcare / Regulatory Compliance
Deliverable
dashboards & analysis | client delivery | infrastructure
Required skills
ISO 13485, 21 CFR 820, EU MDR, CAPA, Internal Audits, Document Control, Change Management, Training Architecture, FDA 510(k), PMA, 21 CFR Part 11, Risk Management (ISO 14971), Root Cause Analysis (5 Why, Fishbone, Fault Tree), Statistical Analysis, Six Sigma
Preferred skills
MS degree, Design History Files, Post-market Surveillance, Validation Planning
Technologies
Quality system software tools, Electronic records systems
Responsibilities
Drive strategic improvements for MQMS aligned with global standards; Lead development and governance of quality processes; Own training process architecture; Serve as SME during FDA and Notified Body inspections; Analyze quality metrics and lead cross-functional initiatives; Provide technical leadership for regulatory submissions; Ensure compliance with 21 CFR Part 11; Lead definition of design history files and risk management docs; Collaborate with R&D, Regulatory, Clinical, and Manufacturing teams; Mentor engineers on quality principles; Lead root cause investigations and failure analysis; Support validation planning for new products; Provide leadership for regulatory inspections.
Seniority
Senior, hands-on IC with strategic input
