Quality Assurance Specialist

2 days ago


New Bedford, Massachusetts, United States Lexington Medical, Inc. Full time
Quality Engineer Intern

Lexington Medical, Inc. is a leading medical device manufacturer in the Boston area, specializing in minimally invasive surgical stapling solutions. Our unique customer-centric approach to engineering has enabled us to be agile and responsive to the stapling market, resulting in 3x revenue growth in the last two years.

Our business structure allows us to produce a range of devices and proprietary technology best suited for leading surgeons and their patients, while adapting quickly to market conditions. We're committed to attracting talented individuals who share our passion for delivering innovation.

As a Quality Engineer Intern, you'll have the opportunity to contribute to the progress of Lexington Medical and its products, gaining business acumen and real-world experience. You'll work on Design Assurance activities throughout the Product Life Cycle, providing support in Risk Management, Design Verification and Validation, Statistical Methods, and Design Controls.

Responsibilities:
  • Participate in Design Assurance activities throughout the Product Life Cycle.
  • Provide support in Risk Management, Design Verification and Validation, Statistical Methods, and Design Controls.
  • Drive quality system execution to US and international standards, including the development of quality and risk management plans.
  • Support regulatory submissions and Technical Documentation.
  • Assist in continuous improvement and CAPA projects.
  • Develop test methods and inspection procedures and implement process control systems to support the development, qualification, and ongoing manufacturing of products.
  • Support supplier quality management, including conducting sub-contractors and component supplier audits.
  • Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
  • Support Post-Market Surveillance (PMS) activities, including complaint handling and investigation, root cause analysis, and vigilance reporting.
  • Be a champion for Quality and support quality disciplines, decisions, and practices.

We're looking for a rising Junior or above attending an accredited university majoring in Biomedical Engineering, Mechanical Engineering, or a similar technical discipline. If you're passionate about quality and innovation, we encourage you to apply.



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