Manager, QA
Core
Lead the Quality Engineering team to ensure effective quality support throughout the product and process lifecycle, focusing on risk management, compliance, and continuous improvement.
Role type
Manager, Quality Engineering
Builds
Medical devices and life science products compliant with 21 CFR Part 820, ISO 13485, and other regulatory standards
Domain
Life Sciences / Medical Devices / Quality Engineering
Required skills
Team leadership, Risk management, Regulatory compliance (21 CFR, ISO 13485), CAPA management, Root cause analysis, Cross-functional collaboration, Data analysis, Process improvement, Audit support, Resource allocation
Preferred skills
Lean methodologies, Statistical methods, Change management, Coaching and development
Technologies
None explicitly stated
Responsibilities
Lead, coach, and develop the Quality Engineering team; Establish procedures for compliance with 21 CFR Part 820, ISO 13485, and related standards; Lead risk management activities for products and processes; Oversee nonconformances, deviations, and complaints investigations; Drive corrective and preventive actions (CAPA); Partner with Engineering and Operations to incorporate quality requirements early in design; Support internal and regulatory audits; Recruit and retain a capable Quality Engineering organization
Seniority
Manager, people leadership & technical direction