Quality Assurance Lead

3 weeks ago


Salt Lake, Utah, United States Flexan Full time

**Job Title:** Quality Assurance Lead

About Flexan:

Flexan is a leading global contract manufacturer of high-quality silicone and thermoplastic components, sub-assemblies, and devices. We serve the medical device industry with precision parts designed to meet critical requirements.

About the Role:

We are seeking a Quality Assurance Lead to ensure our products, processes, and quality records conform to quality standards and establish compliance with our quality system. As a Senior Quality Engineer, you will collaborate with cross-functional team members to facilitate organizational success by safety and meeting business needs.

Key Responsibilities:

  • Process QA requests and ensure timely responses in alignment with quality goals and customer expectations.
  • Lead meetings and communications for QA system information, concerns, and updates.
  • Specialize in areas of quality control engineering, such as design, incoming material, process control, product evaluation, product reliability, inventory control, metrology, automated testing, software, and administrative applications.
  • Analyze and investigate product complaints or reported internal or external quality issues to ensure closure in accordance with company guidelines and external regulatory and customer requirements.

Requirements:

  • Minimum of 3 years of Quality experience.
  • Detailed knowledge of FDA 21 CFR 820, ISO 13485, and GMP.
  • Robust functional knowledge of Failure Mode Effects Analysis (FMEA) and Production Part Approval Process (PPAP).

Compensation and Benefits:

Estimated salary: $80,000 - $110,000 per year, depending on experience. Benefits include health insurance, retirement plan, paid time off, and professional development opportunities.



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