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Sr Quality Engineer

Danvers, MA 01923

Posted: 08/11/2025 Employment Type: Contract Job Category: Engineering Job Number: 620974 Is job remote?: No Country: United States

Job Description


Top 3 technical  skills that are required for the role:
  1. Medical Device Design & Development
  2. Risk Management: dFMEA, pFMEA, Statistical analysis
  3. Technical Writing: IQs, PQs, TMVs

 

Education Required:
  • Bachelor’s Degree in Engineering, Science or technical field AND 4 years of work experience in Engineering and/or Quality OR
  • Advanced Degree in Engineering, Science or technical field AND 2 years of work experience in Engineering and/or Quality

Years’ Experience Required: 4 year

 

What product line will this person support? Cardio vascular, Neurovascular, Peripheral Devices 

 




A Day in the Life

In this exciting role as a Senior Quality Engineer, you will have responsibility for providing comprehensive manufacturing quality support for commercial medical devices in the area of component manufacturing. This includes activities related to test method validation, process validation, inspection improvements, and process/quality change initiatives.

 This is an onsite role at the Danvers, MA location.

Responsibilities Include:
  • Provide Quality Engineering support for commercial medical device products.
  • Develop, modify, apply and maintain quality standards and protocol for processing materials into partially finished or finished materials product.
  • Collaborate with engineering and manufacturing functions to ensure quality standards are in place.
  • Devise and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
  • Design or specify inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
  • May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
  • Apply knowledge of design control principles, statistics, process & systems validation, and quality engineering techniques to positively influence projects and manufacturing.
  • Ensure changes to products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements.
  • Present technical data to groups within and outside the organization.
  • Utilize quality tools to include Risk analysis FMEA, statistical techniques including six-sigma and DOE (design of experiments), root case analysis, reading and correcting drawings.

 Must Have: Minimum Qualifications
  • Bachelor’s Degree in Engineering, Science or technical field AND 4 years of work experience in Engineering and/or Quality OR
  • Advanced Degree in Engineering, Science or technical field AND 2 years of work experience in Engineering and/or Quality.
    Nice to Have: Preferred Qualifications
  • Medical Device
  • Master’s degree
  • Manufacturing Experience
  • Green Belt Six Sigma/DRM Training/Certification
  • ASQ-CQE, CQA, CBA or equivalent certifications
  • SAP QM or SPC Software Experience
  • Effective verbal and written communication, analytical, influencing and interpersonal skills
  • Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), JPAL, and ISO 13485:2016
  • Demonstrated working knowledge of process validation, statistical methods, risk management
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About Danvers, MA

Ready to take the next step in your career? Explore our job opportunities in the vibrant area around Danvers, Massachusetts! Nestled in Essex County, this charming region offers a perfect blend of historic charm and modern amenities, making it an ideal place to live and work. With easy access to picturesque landmarks like Endicott Park and the Peabody Essex Museum, delectable seafood cuisine, and cultural hotspots like the North Shore Music Theatre and The Cabot, there's something for everyone here. Consider joining our team and immerse yourself in the unique culture and endless growth opportunities this enchanting area has to offer!