Manufacturing Quality Specialist

3 days ago


Salt Lake, Utah, United States American Cybersystems Full time
About the Role

We are seeking a highly skilled Manufacturing Quality Specialist to join our team at American Cybersystems. As a key member of our quality assurance team, you will be responsible for ensuring compliance with industry standards and quality system regulations.

Responsibilities
  • Owning or driving non-conforming reports (NCMRs/NCRs) and CAPAs from initiation to closure
  • Performing NCMR tracking and trending (data analysis) to identify improvements for systemic issues
  • Using problem-solving tools (e.g., 5WHYs, Ishikawa) to perform root cause investigations
  • Ensuring maintenance or updating of risk documents such as PFMEAs, DFMEAs, etc.
  • Ensuring compliance with Quality System Regulations (e.g., QSR 21CFR820 and ISO-13485)
Requirements
  • Bachelor's degree from an accredited College or University in Engineering or STEM areas
  • Previous regulated industry experience preferred
  • Minimum of 2 years' experience required in Quality Assurance and/or experience working in an FDA-regulatory environment

The estimated salary for this role is $80,000 - $110,000 per year, depending on qualifications and location.



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