Quality Engineer

1 week ago


St Paul, MN, United States Katalyst Healthcares and Life Sciences Full time
Job Description:
  • This is a 6-month contract with the possibility for extension or conversion.
  • Strong communication skills with excellent attention to detail; ability to follow technical documentation and standard operating procedures in English.
  • We are currently partnering with a client in the medical device industry to fill a Quality Engineer position. The ideal candidate will have proven experience in quality engineering within the medical device sector and demonstrate the ability to work independently.
Responsibilities:
  • Oversee quality activities to ensure compliance with internal procedures and regulatory requirements.
  • Perform inspections, maintain calibration and complaint systems, and manage CAPAs and deviations.
  • Support the production of cannulas, surgical knives, and the packaging of sterile and non-sterile products.
  • Partner with production to ensure operator adherence to SOPs and work instructions.
  • Communicate priorities, completions, and pending items to day shift QEs.
  • Support audits, regulatory inspections, and supplier quality initiatives.
  • Create and maintain quality documentation, procedures, and technical files.
Requirements:
  • Bachelor's degree in engineering preferred; alternatively, 3+ years of experience in the medical device industry with strong technical aptitude.
  • 1+ years of quality engineering or manufacturing experience, with the ability to troubleshoot and resolve production issues.
  • Working knowledge of FDA 21 CFR, ISO 13485, ISO 14971, EU MDR, and Health Canada regulations; understanding of Good Documentation Practices.
  • Experience handling non-conformances and applying engineering principles to medical device products and processes.
  • Proficient in Microsoft Office, Adobe Acrobat, and Visio.
  • Strong communication skills with excellent attention to detail; ability to follow technical documentation and standard operating procedures in English.

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