Katalyst Healthcares and Life Sciences
Manufacturing Quality Engineer
Katalyst Healthcares and Life Sciences, Bothell, Washington, United States, 98021
Job Description:
In this role, you'll ensure manufacturing processes meet quality and regulatory standards while driving improvements across production and compliance. This is a hands-on role with strong cross-functional collaboration and an emphasis on risk management, validation, and problem-solving. Responsibilities:
Support metrology, process mapping, pFMEA, control planning, validations, CAPA, NC, and change management. Assist in reviewing and implementing changes to commercialized products. Conduct failure investigations and root cause analysis. Apply statistics and data analysis to support key decisions. Partner with engineering, logistics, quality, and program management to meet system requirements. Ensure compliance with ISO, FDA, and company quality standards. Requirements:
3-5+ years in medical device manufacturing (ISO14971, 21CFR820, ISO13485, IEC62304, IEC60601). Bachelors in engineering or Life Sciences (master's preferred). Background in manufacturing transfer, process validation, and sustaining mechanical/software-driven devices. Experience with risk management activities, inspection planning, and test method validation. Technical skills in computational tools & electronic QMS. Strong communicator, fast learner, thrives in dynamic environments. Six Sigma (DMAIC) or Lean training/experience. Excellent collaboration & communication skills.
In this role, you'll ensure manufacturing processes meet quality and regulatory standards while driving improvements across production and compliance. This is a hands-on role with strong cross-functional collaboration and an emphasis on risk management, validation, and problem-solving. Responsibilities:
Support metrology, process mapping, pFMEA, control planning, validations, CAPA, NC, and change management. Assist in reviewing and implementing changes to commercialized products. Conduct failure investigations and root cause analysis. Apply statistics and data analysis to support key decisions. Partner with engineering, logistics, quality, and program management to meet system requirements. Ensure compliance with ISO, FDA, and company quality standards. Requirements:
3-5+ years in medical device manufacturing (ISO14971, 21CFR820, ISO13485, IEC62304, IEC60601). Bachelors in engineering or Life Sciences (master's preferred). Background in manufacturing transfer, process validation, and sustaining mechanical/software-driven devices. Experience with risk management activities, inspection planning, and test method validation. Technical skills in computational tools & electronic QMS. Strong communicator, fast learner, thrives in dynamic environments. Six Sigma (DMAIC) or Lean training/experience. Excellent collaboration & communication skills.