Quality Engineer
SciProEagan, MN, United States15 hours ago
Job type
- Temporary
Job descriptionBachelor’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
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 :
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Quality Engineer • Eagan, MN, United States