Quality Manager in Boulder, CO at Tecomet

Date Posted: 11/9/2018

Job Snapshot

Job Description

Job Summary

Under the direction of the Managing Member / EVP, maintains the Quality system as directed.   Responsible for maintaining site adherence to all quality systems requirements.

Essential Job Functions

  • Responsible for understanding the Tecomet Quality Management System (QMS) and effectively maintains quality system.
  • Responsible for maintaining site adherence to all quality systems requirements including, 21 CFR Part 820, ISO 13485:2016 and ISO 14971:2012 standards.
  • Accountable for all qualifications, QC inspections and customer certifications.
  • Regular and consistent departmental communication with customers on quality issues.
  • Maintenance of all necessary documentation per ISO and FDA requirements.
  • Manages quality department personnel including hiring, terminations, performance reviews and mentoring/coaching.
  • Corporate adherence to all documented systems requirements.
  • Effectively handles internal audit obligations.
  • Hosts and manages external audits, including ISO, FDA, other 3rd party, and customer audits.
  • Travel to other plant locations, as needed.
  • Must be flexible with work schedule.
  • Other duties as assigned by management.

Minimum Job Requirements

  • Bachelor’s Degree in engineering and 4+ years related experience. Mechanical engineering degree strongly preferred. 
  • Working knowledge of ISO 13485:2016.
  • Two years of experience in a manufacturing environment.
  • Proficient with Microsoft Office products
  • Excellent communication skills written, verbal and presentation.
  • Excellent organizational skills; documentation

Final candidate must successfully complete a background check and drug screen.

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