Lexington Medical is 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.

Responsibilities

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

Qualifications

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

Quality Engineer

Lexington Medical

Responsibilities

Qualifications

Simplify's Take

What believers are saying

What critics are saying

What makes Lexington Medical unique

Benefits