Quality Engineer
2 weeks ago
- 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.
- 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.
- 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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St Paul, MN, United States Konik Inc Full timeQuality Engineer St. Paul, MN | Direct Hire | $85k - 100k Konik is partnering with a local contract manufacturer who is seeking a driven Quality Engineer to support product development and manufacturing excellence. In this role, you’ll lead part validation, qualification, and sustaining program support while serving as a key resource for customer quality...
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