Sr Eng, Quality
Core
Establish and maintain quality control systems and procedures for medical device manufacturing areas, ensuring regulatory compliance and operational efficiency.
Role type
Senior IC Quality Engineer (Medical Devices)
Builds
Quality systems, validation protocols, and compliance frameworks for medical device production
Domain
Medical Devices / Healthcare Manufacturing
Required skills
Quality control techniques, regulatory compliance (QSR 820, ISO-13485), statistical analysis, root cause analysis, internal auditing, validation activities (IQ/OQ/PQ), Lean principles
Preferred skills
Risk management (ISO13485), FDA Title 21 CFR Part 820 knowledge, European Medical Device Directive knowledge, Post Market Surveillance analysis
Technologies
Statistical sampling methods, Design of experiments, Testing methods
Responsibilities
Ensure compliance with QSR part 820 and ISO-13485; Coordinate scheduling and control of quality resources; Lead ongoing regulatory compliance; Support validation activities (IQs, OQs, PQs); Conduct root cause analysis; Supervise Quality Technicians and Interns; Perform internal audits and Gemba walks; Analyze field data from Post Market Surveillance Reports; Participate in project transfer and gap identification.
Seniority
Senior, hands-on IC