Quality Engineer - Lexington Medical

Lexington Medicalis a medical device manufacturer in the Boston area that produces minimally invasive surgical stapling solutions. Our unique customer-centric approach to engineering has allowed us to be agile and responsive to the stapling market. Our business structure enables us to produce a unique range of devices and proprietary technology best suited for leading surgeons and their patients, while also quickly adapting to the everchanging market conditions.

Our recruiting philosophy is centered on attracting talented individuals committed to delivering innovation. Rooted in a talent dense culture that fosters continuous growth and achievement, both personal and organizationally, we've been organically scaling at a rapid pace and have aggressive hiring plans for the years ahead. By joining Lexington Medical, you will have the opportunity to impact the lives of millions of patients worldwide and thrive in a growing company.

We are looking for a Quality Engineer to join our team based in Bedford, MA office. This is a terrific opportunity for an early-career quality engineer to join a growing medical device company and have a wide-reaching role.

• Contribute to the quality assurance activities throughout the product life cycle in adherence to US FDA, EUMDR, ISO13485, and other global standards
• Drive post-market surveillance efforts to identify potential risks and opportunities for improvement
• Develop and continuously improve complaint handling process and the overall Quality Management System
• Contribute to Risk Management, Design Verification and Validation, Statistical Methods and Design Controls
• Support quality system execution to US and international standards, including development of quality and risk management plans
• Drive continuous improvement projects, and proactively identify and implement best-in-class quality engineering practices
• Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues

• Bachelor's or Master's degree in Engineering or related field
• 1-2+ years of related experience, that would include work/ internships in quality, test engineering, quality engineering, in the medical device industry (experience with electro-mechanical equipment is a plus)
• Experience developing and implementing processes within quality management systems
• Experience in new product development and introduction (NPD/NPI) is helpful
• Some knowledge and/or capability to learn US and international medical device regulations and standards, including 21 CFR 820, EU 2017/45 (MRD), ISO 13485, ISO 14971, IEC 60601, and IEC 62366
• Demonstrated knowledge of design controls, process validation, risk management, and change control
• Demonstrated application of systematic problem-solving techniques and defect avoidance methodologies