Lead Quality Assurance Engineer

2 weeks ago

Woburn, Massachusetts, United States BD Full time
Job Overview

This role will act as the Quality Assurance lead for the manufacturing operations. The main focus will be on addressing production, quality control, and laboratory-related challenges by implementing robust solutions, updating facility documentation for precision and adherence, validating equipment/processes/products as necessary, and recognizing/initiating continuous enhancement initiatives.

About Us

We are the architects of innovation.

BD stands as one of the foremost global medical technology enterprises. Our mission, Advancing the world of healthTM, is a significant endeavor. It requires the creativity and dedication of all our team members—from design and engineering to the production and promotion of our extensive range of MedTech products annually—to confront challenges and discover transformative solutions that turn aspirations into reality.

We value the human aspect within our diverse teams, which enables us to continually progress. Join us and experience an environment where you will be encouraged to learn, develop, and realize your full potential. Become a creator of innovation with us.

Key Responsibilities
  • Lead the Material Review Board (MRB), ensuring effective leadership and coordination for the investigation and resolution of non-conforming products and components.
  • Identify and address challenges in the production of Class III PMA medical device products by designing and executing Quality Assurance investigations, collaborating closely with manufacturing engineers, operators, and other personnel.
  • Provide technical support and mentorship to quality and manufacturing engineers.
  • Document risk-based justifications as required throughout the Quality Management System.
  • Draft and implement validations (IQ/OQ/PQ) and qualification studies for new and existing equipment (inspection & process), software, components, etc.
  • Oversee CAPAs and Audit Action Plans to completion using risk analysis, project management, and appropriate efficiency verification methods.
  • Revise procedures as necessary based on investigations of nonconforming materials, CAPA, complaints, continuous improvement projects (CIP), and compliance with local, division, and corporate procedures, as well as local and international quality regulations.
  • Represent the Quality function on various committees, teams, and task forces as assigned.
  • Support the objectives of the Quality Control Department and the manufacturing operations.
  • Supervise laboratory personnel, quality control, and document management.
  • Engage in special projects as assigned.
Qualifications

Minimum Educational Experience:

  • Bachelor's Degree in Engineering (Chemical, Mechanical, or Biomedical preferred).
  • 5-8 years of experience in medical device quality engineering.
  • Experience in GLP, GMP, and GDP environments.
  • Proficiency in statistics and familiarity with statistical software (e.g., MiniTab).

Preferred Qualifications:

  • Experience in Design Control and Risk Management within pharmaceuticals, combination products, or medical devices.
  • ASQ Certified Quality Engineer (CQE) or advanced degree.
Why Join Us?

A career at BD means being part of a team that values your insights and contributions, encouraging you to bring your authentic self to work. It is a place where we support each other in achieving excellence, uphold integrity, hold one another accountable, and continuously learn and improve.

To find purpose in possibilities, we seek individuals who can envision the broader picture and understand the human narrative that drives our mission. We welcome those with the creativity and determination to help us redefine the future of health. At BD, you will discover a culture that fosters learning, growth, and fulfillment, and find satisfaction in your role in making the world a better place.

  • Lead Quality Assurance Engineer

    1 week ago

    Woburn, Massachusetts, United States Servomex Full time

    Company Overview:Servomex is a recognized leader in the field of gas analysis, committed to enhancing our Quality Team. We are looking for a Senior Quality Engineer to contribute to our high-performing team at our manufacturing facility.Role Overview:The selected candidate will collaborate closely with our manufacturing teams to instill quality in every...

  • Lead Quality Assurance Engineer

    2 weeks ago

    Woburn, Massachusetts, United States Servomex Full time

    Company Overview:Servomex is a global leader in gas analysis technology, dedicated to providing innovative solutions for various industries. We are currently seeking a Senior Quality Engineer to enhance our Quality Team at our manufacturing facility.Role Overview:The ideal candidate will collaborate closely with our manufacturing teams to uphold and elevate...

  • Lead Quality Assurance Engineer

    2 weeks ago

    Woburn, Massachusetts, United States Servomex Full time

    Company Overview:Servomex, a leader in gas analysis technology, is enhancing its Quality Team. This role presents an exceptional opportunity for a Senior Quality Engineer to contribute to our high-performing team.Role Overview:The selected candidate will collaborate closely with our manufacturing teams to foster quality in all operations. Reporting to the...

  • Lead Quality Assurance Engineer

    1 week ago

    Woburn, Massachusetts, United States Servomex Full time

    Company Overview:Servomex, a leader in gas analysis technology, is enhancing its Quality Team. This is a remarkable opportunity for a Senior Quality Engineer to contribute to our esteemed team at our manufacturing facility.Role Overview:The selected candidate will collaborate closely with our manufacturing teams to foster quality in all operations. Reporting...

  • Lead Quality Assurance Engineer

    2 weeks ago

    Woburn, Massachusetts, United States Servomex Full time

    Company Overview:Servomex is a global leader in gas analysis technology, dedicated to delivering innovative solutions and high-quality products. We are currently enhancing our Quality Team, seeking a talented Senior Quality Engineer to contribute to our manufacturing excellence.Role Overview:The ideal candidate will collaborate closely with our manufacturing...

  • Lead Quality Assurance Engineer

    2 weeks ago

    Woburn, Massachusetts, United States Servomex Full time

    Company Overview:Servomex, a global leader in gas analysis technology, is seeking a Senior Quality Engineer to enhance our Quality Team. This role is pivotal in ensuring our manufacturing processes meet the highest standards of quality.Role Summary:The ideal candidate will collaborate closely with our manufacturing teams at the US Technical Center to instill...

  • Quality Assurance Engineer

    2 weeks ago

    Woburn, Massachusetts, United States Guardian Agriculture Full time

    Job OverviewAbout Guardian Agriculture:Guardian Agriculture is at the forefront of developing advanced multicopter technology for the precise application of agricultural chemicals on premium crops. Our innovative systems significantly enhance safety and accuracy compared to traditional aerial spraying methods, while also minimizing chemical usage and...

  • Systems Quality Assurance Engineer

    2 weeks ago

    Woburn, Massachusetts, United States Boyd Company Full time

    Job OverviewThe Systems Quality Assurance Engineer at Boyd Company is tasked with guaranteeing that our products surpass customer expectations and specifications. This role encompasses comprehensive oversight of product quality and acts as the primary liaison for all customer-related product concerns. The engineer will implement necessary measures to enhance...

  • Quality Assurance Engineer for Agricultural Innovations

    1 week ago

    Woburn, Massachusetts, United States Guardian Agriculture Full time

    Job OverviewAbout Guardian Agriculture:Guardian Agriculture is at the forefront of developing advanced multicopter systems designed for the precise application of agricultural chemicals on high-value crops. Our innovative solutions significantly enhance safety and accuracy compared to traditional aerial spraying methods, while also minimizing chemical usage...

  • Quality Assurance Manager

    1 week ago

    Woburn, Massachusetts, United States Fusion Optix Full time

    Job Description:Fusion Optix is seeking a highly skilled and experienced Quality Assurance Manager to join our assembly group, manufacturing LED lighting products.Key Responsibilities:Develop and implement a comprehensive quality assurance strategy aligned with the company's goals and objectives.Establish quality standards, policies, and procedures to ensure...

  • Quality Assurance Manager

    7 days ago

    Woburn, Massachusetts, United States Fusion Optix Full time

    Quality Assurance Manager - LED Lighting Manufacturing GroupJob Overview: We are looking for a dedicated and experienced Quality Assurance Manager to oversee our LED lighting manufacturing group.Position Summary:As a Quality Assurance Manager, you will play a crucial role in maintaining and enhancing the quality of our LED lighting products. Your expertise...

  • Quality Assurance Specialist

    4 days ago

    Woburn, Massachusetts, United States Alsym Energy Full time

    About the RoleWe are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our team at Alsym Energy. As a key member of our organization, you will play a critical role in ensuring the quality and reliability of our products.Key ResponsibilitiesDevelop and Implement Quality Control Systems: Design and implement quality control...

  • Quality Assurance Engineer

    2 days ago

    Woburn, Massachusetts, United States Guardian Agriculture Full time

    Job DescriptionGuardian Agriculture is a leading innovator in the field of autonomous agricultural systems. We are seeking a highly skilled Quality Control Engineer to join our team and contribute to the development of our cutting-edge technology.About UsWe are a small, multi-disciplinary team of talented engineers, technicians, and operators who are...

  • Quality Assurance Engineer for Agricultural Innovations

    1 week ago

    Woburn, Massachusetts, United States Guardian Agriculture Full time

    Job OverviewAbout Guardian Agriculture:Guardian Agriculture is at the forefront of developing advanced multicopter systems designed for the precise application of agricultural chemicals on high-value crops. Our innovative solutions significantly enhance safety and accuracy compared to traditional aerial spraying methods, while also minimizing chemical usage...

  • Quality Assurance Inspector

    2 weeks ago

    Woburn, Massachusetts, United States Verify Full time

    Position OverviewIndustry: Aerospace and DefenseRole: Quality Assurance InspectorEmployment Type: Contractual EngagementWork Schedule: Part-time, 1 hour weekly / 4 hours monthlyJob Responsibilities:The Quality Assurance Inspector is responsible for visiting supplier locations to perform visual and dimensional evaluations on manufactured components,...

  • Quality Assurance Mechanical Inspector

    2 weeks ago

    Woburn, Massachusetts, United States Micro Tech Staffing - Stoughton Full time

    Job OverviewPosition Summary: We are looking for a detail-oriented Quality Assurance Mechanical Inspector to enhance our operations. The successful candidate will possess a strong mechanical understanding, a meticulous approach to quality assurance, and relevant experience in a manufacturing setting.Primary Duties:Conduct thorough inspections of mechanical...

  • Quality Assurance Specialist

    2 weeks ago

    Woburn, Massachusetts, United States Fusion Optix Full time

    Position Overview Fusion Optix is seeking a highly skilled and detail-oriented Quality Technician to join our Assembly Group responsible for manufacturing specification grade LED lighting products. As a Quality Assurance Specialist, you will play a critical role in ensuring that our LED lighting products meet the highest quality standards and...

  • Quality Assurance Specialist

    1 day ago

    Woburn, Massachusetts, United States Digital Prospectors Full time

    Job DescriptionJob Title: Quality Assurance SpecialistJob Summary:Digital Prospectors is seeking a detail-oriented and knowledgeable Quality Assurance Specialist to join their team. The Quality Assurance Specialist will play a crucial role in supporting various areas within UGT Quality Assurance, ensuring compliance with Good Manufacturing Practices (GMP)...

  • Quality Assurance Specialist with Metrology Expertise

    3 days ago

    Woburn, Massachusetts, United States Advantage Technical Full time

    Job Summary:We are seeking a highly skilled Quality Assurance Specialist to join our team at Advantage Technical. As a Quality Assurance Specialist, you will be responsible for ensuring the highest standards of quality in our precision machining processes.Key Responsibilities:Inspect part drawings and dimensions to ensure compliance with linear locations and...

  • Mechanical Quality Assurance Inspector

    2 weeks ago

    Woburn, Massachusetts, United States Aavid Thermal Division of Boyd Corp Full time

    Position Overview:As a Mechanical Quality Assurance Inspector, you will play a crucial role in ensuring the quality and integrity of mechanical products. Your primary responsibility will be to conduct thorough visual and mechanical inspections, utilizing standard measuring tools to confirm that products, materials, and equipment meet the specifications set...