Manager, Quality Assurance & Regulatory Affairs
Core
Oversee the implementation, maintenance, and continuous improvement of the site Quality Management System (QMS) and Regulatory Affairs for assigned locations in highly regulated markets like medical devices and pharma.
Role type
Manager, Quality Assurance & Regulatory Affairs
Builds
Sustainable compliance to customer, state, federal, and International regulatory requirements; leads product release for medical devices.
Domain
Medical Device / Pharma Manufacturing
Required skills
Team leadership, process validation strategy, risk-based approach implementation, root cause analysis, CAPA management, internal audit leadership, quality agreement development, eQMS management, regulatory interpretation, sterile production qualification knowledge.
Preferred skills
ISO class cleanroom experience, USDA Organic food manufacturing knowledge, ISO Lead Auditor certification, ASQ Certified Auditor.
Technologies
eQMS systems, PC systems, Microsoft Office Suite (Word, Excel)
Responsibilities
Provide leadership and support in maintaining and improving site QMS and processes; manage team of Quality Engineers, Supervisors, Specialists, and Auditors; lead product release for medical devices; coordinate activities to maintain ISO 13485, 9001, ISO 14971, ISO 11137, EUMDR, and FDAQSR requirements; inform site management of significant quality issues and facilitate root cause analysis; monitor and measure QMS processes including Quality Objectives, CAPAs, and NCMRs; work with customers and suppliers to develop and approve Quality agreements; oversee Clean room and environmental product controls; lead internal audit process.
Seniority
Manager, hands-on leadership