Quality Engineer

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.

• 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.