Senior Quality Engineer

5 days ago

Bedford, United States Lexington Medical, Inc. Full time
Lexington Medical is a medical device manufacturer in the greater 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.

As a Senior Quality Engineer at Lexington Medical, you will drive the quality system and design assurance activities and play a key role in creating a world-class quality management system and building a quality function that is core to the company's success.

What you will do:
    • Drive Design Assurance activities throughout the Product Life Cycle
    • Provide expertise in Risk Management, Design Verification and Validation, Statistical Methods and Design Controls
    • Define and implement processes within the Quality Management System
    • Drive 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
    • Develop test methods and inspection procedures and implement process control systems to support the development, qualification, and on-going 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
    • Provide guidance to junior members of the team
Requirements:
    • Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, or related field
    • 5+ years of experience in design quality engineering, in the medical device industry (experience with electrical equipment is a plus)
    • Experience developing and implementing processes within quality management systems.
    • Experience in new product development and introduction (NPD/NPI), and in design transfer
    • Strong working knowledge of 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
    • Experience participating in material review boards
    • Supplier quality experience is a plus
    • Strong team orientation and ability to lead in a cross-functional environment

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