Talent.com
Quality Engineer

Quality Engineer

SciProEagan, MN, United States
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This is a 6 month contract with the possibility for extension or conversion.

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.

Key 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.

Qualifications :

  • 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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