Manufacturing Quality Assurance Manager
Core
Lead manufacturing quality assurance activities to ensure products are manufactured and released in compliance with quality standards, regulatory requirements, and company policies.
Role type
Senior Manufacturing Quality Assurance Manager
Builds
Compliant medical device/diagnostics products
Domain
Regulated manufacturing (medical device, pharmaceutical, biotechnology)
Required skills
FDA regulations, ISO 13485, cGMP, Quality Management Systems (QMS), root cause analysis, risk management, data analysis, Lean/Six Sigma
Preferred skills
Advanced degree, professional quality certifications, medical device/diagnostics manufacturing experience, team leadership, stakeholder management
Technologies
QMS tools, data analysis platforms
Responsibilities
Lead and develop a team of quality professionals; ensure compliance with FDA, ISO, and cGMP; oversee batch record review, product disposition, and release activities; manage deviations, investigations, CAPA, and change controls; support regulatory audits and inspections; drive continuous improvement initiatives.
Seniority
Senior, hands-on IC with people leadership
