Manufacturing Quality Engineer

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 and has yielded 3x revenue growth in the last two years. 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 seeking a Manufacturing Quality Engineer to join our team. The ideal candidate will be solutions-oriented, working collaboratively with the production team to maintain the highest standards of quality in our manufacturing processes. This role focuses on continuous improvement and compliance with regulatory standards, ensuring our products meet the highest quality requirements.

What you will do:

• Develop and conduct process and equipment validation and verification activities, including risk assessments.
• Communicate with suppliers and contract assembly facilities to ensure a coherent product quality system.
• Construct a systematic approach to understanding outgoing product quality using sampling plans and non-destructive testing.
• Perform root cause analysis on quality issues and non-conformances, and implement corrective and preventive actions.
• Maintain accurate documentation related to quality activities, including inspection records, test results, and audit reports.

Responsibilities:

• Bachelor’s degree in Engineering
• 2+ years of experience in quality engineering within a manufacturing environment; medical device industry experience preferred.
• Sense of mechanical intuition and ability to quickly understand complex electro-mechanical systems.
• Excellent communication and interpersonal skills, with the ability to work effectively in a collaborative, team-oriented environment.
• Strong organizational and project management skills, with attention to detail.