Quality Assurance Manager
Core
Define, implement, and sustain quality systems, policies, and processes for regulatory compliance, product integrity, and patient safety in a medical device manufacturing environment.
Role type
Senior Quality Management Manager (Medical Devices)
Builds
Quality Management Systems, regulatory compliance frameworks, and risk-based quality strategies for sterile and non-sterile medical devices.
Domain
Medical Device Manufacturing / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
FDA 21 CFR Part 820, ISO 13485, MDSAP, sterile product oversight, risk-based decision making, CAPA management, regulatory inspection leadership, data analysis, team development
Preferred skills
10+ years in medical device quality, engineering degree, external sterilization process knowledge
Technologies
FDA 21 CFR Part 820, ISO 13485, MDSAP
Responsibilities
Lead development and continuous improvement of the Quality Management System; oversee QA activities for sterile and non-sterile products; lead risk-based decisions on product quality holds; represent the site during regulatory inspections and audits; drive complaint handling and investigation processes; monitor quality data and KPIs to drive improvements; lead Site Quality Management Reviews; coach and develop the Quality organization.
Seniority
Senior, hands-on IC with strategic leadership