Sr. Manager, Medical Device Quality Assurance
Core
Lead QA oversight for Combination Products Sustaining Engineering and Compliance, managing teams and ensuring regulatory readiness.
Role type
Senior Manager, Medical Device Quality Assurance
Builds
Combination product quality management systems and regulatory compliance frameworks
Domain
Pharmaceutical/Medical Device
Deliverable
client delivery
Required skills
Quality engineering leadership, compliance management, risk assessment, design change management, Design History File maintenance, Risk Management File maintenance, Design Review participation, QMS policy ownership, regulatory inspection support, contract organization management
Preferred skills
Combination product lifecycle knowledge, digital tool implementation for reporting
Technologies
Digital reporting tools
Responsibilities
Manage and mentor quality engineering and compliance teams; Standardize and improve QA processes; Support sustaining engineering programs with risk and design change management; Act as Management Representative for combination product QMS; Support regulatory inspections and partner audits
Seniority
Senior, hands-on IC with people leadership
