Lexington Medical is seeking a Quality Engineering Manager to manage and develop a team of quality engineers while driving design assurance and compliance across the product lifecycle for their minimally invasive surgical stapling solutions.
Requirements
- 8+ years of experience leading design quality engineering in the medical device industry, including experience supporting the developing and maintenance of medical devices that have software capabilities.
- Proven track record in new product development (NPD/NPI), design transfer, and sustaining engineering.
- Strong knowledge of medical device regulations and standards: 21 CFR 820, EU MDR, ISO 13485, ISO 14971, IEC 60601, IEC 62366.
- Demonstrated expertise in design controls, risk management, CAPA, complaint handling, and change control.
- Experience with sterilization validation, biocompatibility testing, cleanroom practices, or microbiology is a plus.
- Skilled in audit preparation and execution for both internal and external inspections.
- CQE certification or equivalent preferred; experience with Arena eQMS a plus.
Responsibilities
- Lead design quality assurance activities throughout the product lifecycle, from requirements and development through V&V, design transfer, commercialization, and post-market support.
- Provide expertise in Risk Management, Design Verification and Validation, Statistical Methods, Design Controls, and Usability Engineering for both new product introductions and commercially available products.
- Review and approve product requirements, test documentation, and design reviews.
- Expert interpretation of global medical device regulations and standards (21 CFR 820, EU MDR, ISO 13485, ISO 14971, IEC 60601, IEC 62366, etc.).
- Oversee the Corrective and Preventive Action (CAPA) process, ensuring thorough investigation, root cause analysis, implementation, and effectiveness checks.
- Support internal audits, external regulatory inspections, and third-party audits.
- Oversee post-market surveillance, including trend analysis, risk assessments, and feedback into product improvement.
Other
- Manage, mentor, and develop quality engineers, fostering growth, collaboration, and technical excellence.
- Drive cross-functional collaboration with R&D, Regulatory, Operations, and Manufacturing to ensure quality is embedded at every stage of product development and production.
- Manage sterilization requalification processes.
- Responsible for supplier quality audit program.
- Partner with quality team to strategically enhance the Quality Management System (QMS) to meet evolving business and regulatory needs.
