Process Control Engineer

3 weeks ago


Salt Lake, Utah, United States Flexan Full time

**Company Overview:**

Flexan is a leading global contract manufacturer of custom high-quality silicone and thermoplastic components, sub-assemblies, and devices designed to meet critical requirements of Class I, Class II, and Class III medical devices.

Job Description:

We are seeking a Senior Quality Engineer to assure products, processes, and quality records conform to quality standards and establish compliance with our quality system. The successful candidate will be responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by safety and meeting business needs.

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).

Benefits:

Estimated salary: $90,000 - $120,000 per year, depending on experience. Benefits include health insurance, retirement plan, paid time off, and professional development opportunities.



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