Manager, QA
Core
Lead Quality Engineering activities supporting product and process design, new product introduction, risk management, nonconformances, deviations, CAPAs, complaints, and continuous improvement.
Role type
Manager, Quality Engineering
Builds
Medical devices and life science products compliant with regulatory standards
Domain
Life Sciences / Medical Devices
Required skills
Quality Engineering leadership, Risk Management, CAPA management, Nonconformance investigation, Regulatory compliance (21 CFR, ISO 13485), Cross-functional collaboration, Team development, Data analysis, Lean methodologies
Preferred skills
None stated
Technologies
None stated
Responsibilities
Lead and develop the Quality Engineering team; Establish procedures for compliance with 21 CFR Part 820, ISO 13485, and related standards; Provide quality leadership for product design and NPI activities; Lead risk management activities for products and processes; Oversee nonconformance and deviation investigations; Drive corrective and preventive action (CAPA) initiatives; Support complaint investigations; Champion continuous improvement initiatives.
Seniority
Manager, hands-on leadership
