Senior Quality Engineer

Lexington Medical is a medical device company, developing and manufacturing minimally invasive surgical stapling solutions in the Boston area. With the highest standards in design engineering and smart manufacturing, our team delivers disruptive technology to health care providers which improves surgical outcomes for their patients in a thriving $6B+ Surgical Stapler market. 

Rooted in a talent dense culture, we are committed to innovation, foster continuous growth and achieve great heights, together. At Lexington Medical, you will have the opportunity to impact the lives of millions of patients worldwide and thrive in a growing company.

We are growing and hiring a Senior Quality Engineer to join us in Bedford, MA. As a Senior Quality Engineer at Lexington Medical, you will drive the quality system and design assurance activities and play a key role in maintaining a world-class quality management system and building a quality function that is core to the company’s success.

Responsibilities:

• Drive design quality assurance activities throughout the product lifecycle. Lead design quality activities for product development, starting from the requirements phase through development, V&V, design transfer, and commercialization.
• Provide expertise in Risk Management Files, Design Verification and Validation, Statistical Methods, Design Controls, and Usability activities for new product introductions as well as commercially available products.
• Provide guidance on statistical techniques by participating in V&V and engineering testing sampling plans.
• Review and support product requirements, test documentation, and design reviews.
• Provide input for interpretation of global standards and guidelines.
• Assist with the Corrective and Preventive Action (CAPA) process, including identification, investigation, root cause analysis, implementation, and effectiveness monitoring.
• Conduct and support internal audits to ensure compliance with quality management system requirements and identify areas for improvement.
• Participate in external audits, including preparation, coordination, and response to findings from regulatory bodies or third-party auditors.
• Assist with post-market surveillance activities, including planning, data collection, trend analysis, and risk assessments.
• Create/review engineering and document change orders.

Qualifications:

• Bachelor’s or Master’s degree in Biomedical Engineering, Mechanical Engineering, or related field.
• 5+ years of experience in design quality engineering in the medical device industry, including experience supporting the developing and maintenance of medical devices that have software capabilities.
• Experience developing and implementing quality management systems.
• Experience in new product development and introduction (NPD/NPI) and production transfer.
• Strong working knowledge of US and international medical device regulations and standards, including 21 CFR 820, EU 2017/45 (MDR), ISO 13485, ISO 14971, IEC 60601, and IEC 62366.
• Experience with sterilization validation and biocompatibility testing a plus.
• Demonstrated knowledge of design controls, process validation, risk management, CAPA processes, complaint handling, and change control.
• Demonstrated application of systematic problem-solving techniques and defect avoidance methodologies.
• Experience with internal and external auditing processes, including audit preparation, execution, and follow-up.
• Strong team orientation and ability to lead in a cross-functional environment.
• CQE or equivalent certifications a plus; Arena eQMS experience a plus.
• Clean room and/or microbiology experience a plus.