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Manufacturing Jobs

Quality Engineer

Karwell Technologies

  • Boston, MA
  • 30+ days ago

    Highlights

    Job Summary: Seeking a Quality Engineer with 5+ years of experience in the medical device industry to support process verifications/validations, design quality engineering, design controls, risk management, and quality systems. The ideal candidate should have strong problem-solving, collaboration, and project leadership skills, with experience in Design/Process FMEA and product testing.

    Numbers & Facts

    LocationBoston, MA

    Description

    Job Summary:
    • Seeking a Quality Engineer with 5+ years of experience in the medical device industry to support process verifications/validations, design quality engineering, design controls, risk management, and quality systems. The ideal candidate should have strong problem-solving, collaboration, and project leadership skills, with experience in Design/Process FMEA and product testing.
    Roles & Responsibilities:
    • Conduct Process Verifications/Validations.
    • Perform Design and/or Process Failure Modes and Effects Analysis (FMEA).
    • Perform blueprint reading, inspection methods, and GD&T.
    • Ensure smooth implementation by working with the onsite team and managing project priorities.
    • Collaborate with senior leadership on long-term strategy for the area/site.
    • Perform risk management and execute product testing.
    • Work on Quality Systems, including CAPA, nonconforming materials, risk management, and medical device regulations.
    • Communicate effectively in both written and verbal formats and utilize Microsoft Word, Excel, and Outlook.
    Education & Experience:
    • 5+ years of work experience in the medical device industry.
    • Experience conducting Process Verifications/Validations.
    • Experience conducting Design and/or Process Failure Modes and Effects Analysis (FMEA).
    • Design Quality Engineering experience.
    • Design Control experience.
    • Excellent problem-solving and decision-making skills.
    • Strong interpersonal, collaboration, initiative, and project leadership skills.
      • Advanced degree.
      • Bachelor's degree in Mechanical Engineering or Bioengineering.
      • New Product Development experience.
      • Experience with blueprint reading, inspection methods, and GD&T.
      • Strong experience with Design Excellence, Six Sigma, or Lean.
      • Spanish as a second language.

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