Lead Quality Assurance Engineer with a Focus on Compliance and Excellence

24 hours ago


Salt Lake, Utah, United States Flexan Full time

Are you looking for a challenging role that requires expertise in quality assurance, compliance, and process improvement? We are seeking a Senior Quality Engineer to join our team at Flexan.

About the Role

The estimated annual salary for this position is $85,000 - $110,000, depending on experience. As a Senior Quality Engineer, you will be responsible for ensuring that products, processes, and quality records conform to quality standards and establish compliance with the quality system. This includes collaborating with cross-functional teams to facilitate organizational success, leading on-time completion of Quality Assurance (QA) engineering deliverables, and interpreting and complying with Flexan's quality assurance standards.

Key Responsibilities
  • Process QA requests and ensure timely responses are provided 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.
  • Work with Production on Continuous Improvement (CI) projects.
  • 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

To be successful in this role, you will need:

  • A 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).
About Flexan

Flexan is a global strategic contract manufacturer of custom high-quality silicone and thermoplastic components, sub-assemblies, and devices designed to meet the critical requirements of Class I, Class II, and Class III medical devices. We value our employees and offer a competitive benefits package, including opportunities for professional growth and development.



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