Manufacturing Quality Engineer

6 days ago


Bedford, Massachusetts, United States Lexington Medical, Inc. Full time

Lexington Medical is a renowned medical device manufacturer based in the Boston area, specializing in innovative minimally invasive surgical stapling solutions.

Our customer-centric engineering approach has led to remarkable growth, tripling our revenue over the past two years.

At Lexington Medical, we develop a diverse range of devices and cutting-edge technology tailored to meet the needs of top surgeons and their patients, while remaining adaptable to market changes.

Our recruitment strategy focuses on attracting talented individuals dedicated to driving innovation. Rooted in a culture of talent and growth, both on a personal and organizational level, we are experiencing rapid, organic expansion and have ambitious hiring goals for the future.

By becoming part of Lexington Medical, you will have the opportunity to make a meaningful difference in the lives of countless patients worldwide and thrive in a dynamic and growing organization.

We are currently looking for a Manufacturing Quality Engineer to join our team.

The ideal candidate will be proactive and collaborative, ensuring the highest quality standards in our manufacturing processes.

This role is dedicated to continuous enhancement and compliance with regulatory requirements, guaranteeing top-quality products.

Tasks:
- Develop and carry out process and equipment validation and verification activities, including risk assessments.
- Liaise with suppliers and contract assembly facilities to uphold a cohesive product quality system.
- Establish a methodical approach to grasp outgoing product quality through sampling plans and non-destructive testing.
- Conduct root cause analysis on quality issues and non-conformities, implementing corrective and preventive measures.
- Maintain precise documentation related to quality procedures, such as inspection records, test outcomes, and audit reports.

Requirements:
- Bachelor's degree in Engineering
- 2+ years of quality engineering experience in a manufacturing setting, preferably in the medical device industry.
- Strong mechanical insight and the ability to comprehend complex electro-mechanical systems quickly.
- Exceptional communication and interpersonal skills, thriving in a cooperative, team-based environment.
- Effective organizational and project management capabilities, with keen attention to detail.

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