Are you a strategic leader passionate about quality engineering in the medical device industry?

We are working with a Medical Device company looking to hire a Director of Quality Engineering to spearhead New Product Development (NPD) and New Product Introduction (NPI) activities while ensuring compliance.

This is a fantastic opportunity to drive innovation, mentor a talented team, and shape the future of high-quality medical device solutions.

Key Responsibilities:

• Lead quality engineering activities for NPD/NPI projects, ensuring timely delivery within scope, schedule, and quality objectives.
• Collaborate with cross-functional teams to identify risks, develop mitigation strategies, and resolve issues.
• Mentor and manage a team of quality engineers, fostering a culture of excellence and accountability.
• Apply Design Control principles and develop quality processes for activities such as design verification/validation, process validation, and risk management.
• Oversee risk management processes, including Health Hazard Analysis (HHA), failure mode analysis, and process validation.
• Support design transfer activities and remediation projects for both domestic and international initiatives.
• Ensure inspection readiness and regulatory compliance across quality engineering processes.
• Drive quality improvement initiatives and contribute to product realization, including early-stage development, component engineering, and prototype testing.

Qualifications:

• Bachelor’s degree in Engineering, Science, or a technical field (advanced degree preferred).
• 15+ years of experience in quality engineering within a regulated medical device industry.
• Proven leadership and team management experience.
• In-depth knowledge of medical device quality standards, including risk management, design validation, and process characterization.
• Expertise in advanced statistical methods (e.g., Minitab, DOE, capability analysis) and reliability analysis.
• Six Sigma certification or ASQ certifications are advantageous.
• Proficiency in SolidWorks, inspection tools, and Microsoft Office Suite.