Quality Assurance Manager

19 hours ago


Saint Charles, Missouri, United States AJR Enterprises, LLC. Full time
Job Summary

We are seeking a highly experienced Quality Assurance Manager to lead our quality related engineering needs. This role involves compliance and risk analysis, process validation, and regulatory submissions.

Responsibilities
  • Lead in supporting compliance for medical device manufacturer in ID/Traceability throughout supply chain, well documented and executed Acceptance Activities, Non-conforming material management, Packaging/Labeling control, Production/Process controls, Process Validation.
  • Risk Assessments, project meetings, pilot builds, First Article Inspections, and Post Market Risk Management
  • Designs and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and/or production equipment.
  • Design and execution of pFEMA's, IQ, OQ, PQ and PPQ validation
  • Corrective and Preventive Action management, facilitation, ownership and problem resolution
  • Process improvement and support, including Quality System process review and revision.
  • Training assistance, including providing training in quality system activities/requirements
  • Internal and external audit coordination and facilitation

Requirements:

  • A Bachelor's degree in science, engineering or equivalent
  • 10 or more year's relevant experience
  • At least 5 years' experience in medical device manufacturing
  • Strong knowledge of Quality Systems policies and regulations (ISO 13485 and FDA Part 820) with a strong background in medical device quality assurance and processes
  • Experience conducting supplier audits and writing supplier contracts.
  • Familiarity with statistical analysis.
Estimated Salary

$120,000 - $150,000 per year



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