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Job description
Responsibilities Manage and mentor quality engineering and compliance teams
Oversee sustaining engineering programs including risk assessment and design change management
Act as Management Representative for combination products quality management system
Support regulatory inspections and partner audits for combination products
Implement data-driven tools for reporting and process improvement
Requirements
Bachelor's degree in Engineering or equivalent education and experience
8+ years medical device or combination product experience
Previous supervisory or people leadership experience
Knowledge of combination device development and lifecycle processes
Quality management system and regulatory compliance expertise
Compensation: $126,300-$206,100 base annually
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.