Manufacturing Quality Engineer
Manufacturing Quality Engineer
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Salary Not Disclosed
1 Vacancy
Job Description
- In this role youll 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 (ISOCFR820 ISO13485 IEC62304 IEC60601).
- Bachelors in engineering or Life Sciences (Masters 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.
Employment Type
Full-time
