What are the responsibilities and job description for the Director of Quality position at Lumicity?
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 :