Sr. Manager, Medical Device Quality Assurance
Core
Lead a team of engineers and quality specialists to provide QA oversight for Combination Products Sustaining Engineering and Compliance functions.
Role type
Senior Manager, Medical Device Quality Assurance
Builds
Combination product quality management systems and regulatory compliance for sustaining engineering programs
Domain
Medical Device / Pharmaceutical
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, Partner/contract organization management
Preferred skills
Combination product development lifecycle knowledge
Technologies
Digital data-driven reporting tools
Responsibilities
Manage and mentor quality engineering and compliance teams; Standardize and improve processes across sustaining and compliance; Implement digital tools for reporting; Support sustaining engineering programs with risk assessment and design change management; Act as Management Representative for combination products QMS; Support regulatory inspections and partner audits
Seniority
Senior, hands-on IC with people leadership