Manufacturing Quality Engineer

This is a hands-on role with strong cross-functional collaboration and an emphasis on risk management, validation, and problem-solving.

• 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.

• 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.

• 3-5+ years in medical device manufacturing (ISO
  14971, 21
  
  CFR
  820, ISO
  13485, IEC
  62304, IEC
  60601).
• 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.

We are an equal opportunities employer and welcome applications from all qualified candidates.