Quality Engineer

3 weeks 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. 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 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 CycleProvide expertise in Risk Management, Design Verification and Validation, Statistical Methods and Design ControlsDefine and implement processes within the Quality Management System Drive quality system execution to US and international standards, including development of quality and risk management plansDrive continuous improvement projects, and proactively identify and implement best-in-class quality engineering practicesDevelop test methods and inspection procedures and implement process control systems to support the development, qualification, and on-going manufacturing of productsSupport supplier quality management, including conducting sub-contractors and component supplier auditsApply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issuesRequirements:Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, or related field2+ 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 transferStrong 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 62366Demonstrated knowledge of design controls, process validation, risk management, and change controlDemonstrated application of systematic problem-solving techniques and defect avoidance methodologiesExperience participating in material review boardsSupplier quality experience is a plusStrong team orientation and ability to lead in a cross-functional environment

  • Quality Engineer

    2 months ago

    Bedford, United States Entegris Full time

    Job Title:Quality EngineerJob Description:The Role: Our site in Bedfordis seeking a Quality Engineer to join our team! The Quality Engineer will work with our team Quality Engineers and Process Engineers supporting the Bedford, MA site. Our site manufactures Ultra-high molecular weight polyethylene (UPE) membrane and Metal Membrane products. Production is...

  • Quality Engineer

    2 weeks ago

    Bedford, United States Entegris Full time

    Job Title: Quality Engineer Job Description: The Role: Our site in Bedfordis seeking a Quality Engineer to join our team! The Quality Engineer will work with our team Quality Engineers and Process Engineers supporting the Bedford, MA site. Our site manufactures Ultra-high molecular weight polyethylene (UPE) membrane and Metal Membrane products. Production...

  • Quality Engineer

    4 days ago

    Bedford, United States Actalent Full time

    A great opportunity to work with a growing Robotics company! Job Description •Lead the development and execution of comprehensive hardware quality assurance plans. •Design, implement, and oversee testing protocols for hardware components and systems. •Conduct root cause analysis and drive corrective actions to address quality issues. •Collaborate...

  • Quality Engineer

    7 days ago

    Bedford, United States Actalent Full time

    A great opportunity to work with a growing Robotics company! Job Description Lead the development and execution of comprehensive hardware quality assurance plans. Design, implement, and oversee testing protocols for hardware components and systems. Conduct root cause analysis and drive corrective actions to address quality issues. Collaborate with...

  • Senior Quality Engineer

    4 weeks ago

    Bedford, United States InfraredX, Inc. Full time

    Senior Quality EngineerProvide engineering support to ensure the quality of design, sourcing and manufacturing of products at Infraredx. Provide input to the development teams in the manufacturing transfer of complex electromechanical medical devices. Develop, review, and implement engineering changes. Support establishment of quality inspection criteria....

  • Senior Quality Engineer

    1 month ago

    Bedford, United States InfraredX, Inc. Full time

    Job DescriptionJob DescriptionSenior Quality EngineerProvide engineering support to ensure the quality of design, sourcing and manufacturing of products at Infraredx. Provide input to the development teams in the manufacturing transfer of complex electromechanical medical devices. Develop, review, and implement engineering changes. Support establishment of...

  • Senior Quality Engineer

    1 month ago

    Bedford, United States Infraredx, a Nipro Company Full time

    Provide engineering support to ensure the quality of design, sourcing and manufacturing of products at Infraredx. Provide input to the development teams in the manufacturing transfer of complex electromechanical medical devices. Develop, review, and implement engineering changes. Support establishment of quality inspection criteria. Develop, establish and...

  • Senior Quality Engineer

    1 month ago

    Bedford, United States Infraredx, a Nipro Company Full time

    Provide engineering support to ensure the quality of design, sourcing and manufacturing of products at Infraredx. Provide input to the development teams in the manufacturing transfer of complex electromechanical medical devices. Develop, review, and implement engineering changes. Support establishment of quality inspection criteria. Develop, establish and...

  • Hardware Quality Engineer

    6 days ago

    Bedford, Massachusetts, United States Actalent Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at Actalent. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and reliability of our products.Key ResponsibilitiesDevelop and execute comprehensive quality assurance plans to ensure the quality and reliability of our...

  • Quality Engineer Co-Op

    7 days ago

    Bedford, United States Entegris Full time

    Job Title: Quality Engineer Co-Op Job Description: Quality Engineer Co-Op - Spring 2025 Here at Entegris, we use advanced science to enable technologies that transform the world, and we are seeking employees who have the drive to continue the mission. The Role: Our site in Bedford is seeking a/an Quality Engineer Co-Op to join our team for the Spring 2025...

  • Senior Quality Engineer

    3 months ago

    Bedford, United States Entegris Full time

    Company Overview and Values: Why work at Entegris? Lead. Inspire. Innovate. Define Your Future. Not everyone who works for a global company shares the same background, experiences and perspectives. We leverage the differences of our employees to bring new ideas to the table. Every employee throughout the company is encouraged to share input on projects and...

  • Quality System Engineer

    1 month ago

    Bedford, United States InfraReDx Full time

    Responsibilities• Supports the complaint handling process for the organization. Responsible for activities required to ensure compliance of Infraredx Quality Management Systems (QMS), specifically regarding Customer Complaints. Additional responsibilities include supporting other QMS functions such as Management Review, CAPAs, NMRs, Risk Review, etc. •...

  • Quality System Engineer

    23 hours ago

    Bedford, United States InfraReDx Full time

    Responsibilities• Supports the complaint handling process for the organization. Responsible for activities required to ensure compliance of Infraredx Quality Management Systems (QMS), specifically regarding Customer Complaints. Additional responsibilities include supporting other QMS functions such as Management Review, CAPAs, NMRs, Risk Review, etc. •...

  • Quality Engineer Co-Op

    4 days ago

    Bedford, United States Entegris Full time

    Job Title:Quality Engineer Co-OpJob Description:Quality Engineer Co-Op - Spring 2025Here at Entegris, we use advanced science to enable technologies that transform the world, and we are seeking employees who have the drive to continue the mission.The Role:Our site in Bedford is seeking a/an Quality Engineer Co-Op to join our team for the Spring 2025 season....

  • Lead Quality Assurance Engineer

    1 week ago

    Bedford, Massachusetts, United States InfraredX, Inc. Full time

    Lead Quality Assurance EngineerAs a Lead Quality Assurance Engineer at InfraredX, you will play a crucial role in ensuring the excellence of our product designs, sourcing, and manufacturing processes. Your expertise will guide the development teams during the transition of intricate electromechanical medical devices from concept to production. You will be...

  • Manufacturing Quality Engineer

    2 weeks ago

    Bedford, United States Coravin Full time

    The Opportunity This role is for an entry level manufacturing engineer and will require active learning and training on the job. Reporting to the VP of Engineering, the successful candidate will contribute to and/or lead Initiatives relating to configuration management, product quality, validation, and manufacturing at all stages of the product lifecycle....

  • Quality Assurance Engineer I

    2 weeks ago

    Bedford, United States IDEMIA Full time

    Overview: IDEMIA is the global leader in identity and security. Our mission is to create a safe and simple future where identity verification is indisputable, and only you can assert your identity. We are a distributed company leveraging the latest technologies to deliver world-class products in the private and public sectors of finance, telecom, identity,...

  • Quality Assurance Engineer I

    4 weeks ago

    Bedford, United States IDEMIA Full time

    Overview IDEMIA is the global leader in identity and security. Our mission is to create a safe and simple future where identity verification is indisputable, and only you can assert your identity. We are a distributed company leveraging the latest technologies to deliver world-class products in the private and public sectors of finance, telecom, identity,...

  • Principal Supplier Quality Engineer

    3 months ago

    Bedford, United States Infraredx, a Nipro Company Full time

    Responsible for ensuring that Infraredx’s suppliers provide high quality materials and/or services that conform to the needs of Infraredx product quality and regulatory requirements. Key team member providing expertise on the capability of our suppliers, in establishing and maintaining the technical activities of our suppliers, and ensuring they meet...

  • Principal Supplier Quality Engineer

    3 months ago

    Bedford, United States InfraredX, Inc. Full time

    Job DescriptionJob DescriptionResponsible for ensuring that Infraredx’s suppliers provide high quality materials and/or services that conform to the needs of Infraredx product quality and regulatory requirements. Key team member providing expertise on the capability of our suppliers, in establishing and maintaining the technical activities of our...