Quality Engineering Manager

We are seeking an experienced Quality Engineering Manager to lead a high-performing quality team within a growing medical device organization. This role will partner closely with Engineering, Manufacturing, Operations, Regulatory Affairs, and Supply Chain to ensure products are designed, manufactured, and maintained in compliance with applicable regulatory requirements and quality standards.

The ideal candidate brings deep expertise in medical device quality systems, strong leadership capabilities, and a passion for driving continuous improvement across the product lifecycle.

What You'll Do

• Lead and develop the Quality Engineering team, fostering a culture of quality, collaboration, and continuous improvement.
• Partner cross-functionally with Engineering, Manufacturing, Operations, Regulatory Affairs, and Supply Chain to support product development and commercial manufacturing activities.
• Oversee quality initiatives throughout the product lifecycle, including design controls, risk management, verification and validation, process validation, complaint handling, CAPA, audits, and nonconformance management.
• Ensure compliance with applicable regulations and standards, including FDA Quality System Regulations, ISO 13485, MDSAP, EU MDR, and internal Quality Management System (QMS) requirements.
• Support FDA inspections, notified body audits, and external quality audits.
• Lead root cause investigations and drive effective corrective and preventive actions.
• Monitor and enhance quality system effectiveness through data analysis, process improvements, and key performance indicators.
• Collaborate with stakeholders across all levels of the organization to identify and mitigate quality risks.

Required Qualifications

• Bachelor's degree in Science, Engineering, or a related technical discipline.
• Minimum of 7 years of experience in Quality Engineering, Quality Assurance, or Quality Systems within the medical device industry.
• Strong knowledge of FDA Quality System Regulations, ISO 13485, MDSAP, EU MDR, and medical device quality requirements.
• Experience supporting product development and manufacturing activities, including design controls, risk management, verification and validation, and process validation.
• Working knowledge of inspection specification development, statistical analysis techniques, gage R&R studies, and GD&T applications.
• Experience leading or participating in CAPA activities, complaint investigations, root cause analysis, and nonconformance management.
• Prior experience supporting FDA inspections, notified body audits, and external quality audits.
• Excellent communication, leadership, organizational, and problem-solving skills.
• Proven ability to influence and collaborate effectively across cross-functional teams.

Preferred Qualifications

• Master's degree in Science, Engineering, or a related technical discipline.
• Previous people leadership or Quality Engineering management experience within a medical device organization.
• Orthopedic medical device industry experience.
• Experience leading quality teams supporting both new product development and commercial manufacturing.
• Demonstrated success driving continuous improvement initiatives and quality system enhancements.
• Professional certifications such as Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent through the American Society for Quality.
• Experience working in highly regulated global environments supporting multiple regulatory jurisdictions.

Why Join Us?

• Competitive compensation package with annual bonus opportunity
• Comprehensive benefits package
• Opportunity to make a direct impact on products that improve patient outcomes
• Collaborative, cross-functional environment with strong leadership support
• Career growth opportunities within an innovative medical device organization

If you're passionate about quality, regulatory excellence, and leading teams in a highly regulated environment, we'd love to connect. Apply today to learn more.