Sr. Quality Assurance Engineer
Core
Provide quality leadership for assigned product families throughout the product lifecycle, partnering with Product Management, R&D, Operations, Service, and Purchasing to monitor performance and drive risk-based improvements.
Role type
Senior Quality Assurance Engineer (Medical Device/Regulated Industry)
Builds
Quality Management System compliance and product/process quality metrics for medical/optical products
Domain
Medical Technology / Optical / Semiconductor Manufacturing
Required skills
Quality assurance leadership, complaint investigation, root-cause analysis, CAPA, risk management, statistical methods (sampling, process capability), regulatory compliance (ISO 13485, FDA 21 CFR Part 820), project management
Preferred skills
Medical electronic, ophthalmic, optical, or similar regulated product experience
Technologies
ISO 13485, FDA 21 CFR Part 820, Statistical analysis tools
Responsibilities
Monitor product and process performance, translate customer/regulatory requirements into quality objectives, manage escalated product complaints, lead complex quality investigations and root-cause analyses, support regulatory inspections and audits, lead quality projects and provide technical guidance
Seniority
Senior, hands-on IC