Quality Engineer

medtechrec
Any Location, NC
Job Description
The Quality Engineer plays a pivotal role in ensuring that products meet internal quality standards and comply with all applicable medical device regulatory requirements.

Requirements

  • Ensure adherence to relevant quality standards and regulations
  • Collaborate with contract manufacturing partners
  • Address customer feedback, audit outcomes, and concerns
  • Investigate nonconformances and lead root cause analyses
  • Implement corrective and preventive actions
  • Maintain detailed records of quality incidents and resolutions
  • Lead or assist in validation of equipment, manufacturing processes, and testing methods
  • Collaborate with procurement and supplier quality teams
  • Participate in supplier audits and resolve supplier-related quality concerns
  • Drive process and quality improvement initiatives
  • Contribute to preparation for internal, customer, and third-party audits
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