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QA Supervisor & Document Control

Position Summary:

The desired candidate will have experience working as a “hands-on” Supervisor of Quality and Documentation Control, preferably working in a medical device company. Specific experience and responsibilities will include, but not limited to: supervision of Quality Inspectors and Documentation Control staff; organize and direct workload; create, monitor and report metrics to both team and management; conduct weekly team meetings to discuss projects and enhance communication.

 

Essential Function / Major Responsibilities:

  • Provide supervision to QA and Documentation Control staff members
  • Conduct weekly QA and Documentation Control team meetings
  • Create individual employee goals and monitor performance
  • Address performance issues in an encouraging and timely manner
  • Ensure all inspections are performed in a timely manner and without issue
  • Alert QA Management regarding questionable measurements and/or non-conforming parts
  • Review inspection documentation ensuring requirements are met
  • Complete NCMR’s as required
  • Ensure all calibration and measurement tools are in working order
  • Monitor and verify that First Article inspections are conducted per customer requirements
  • Conduct 1st piece approvals
  • Conduct root cause analysis on non-conforming parts
  • Create and publish metrics monthly on all QA and Documentation Control projects both in-process as well as completed
  • Verify completion and accuracy of inspection records
  • Ensure compliance with ISO-13485 and FDA CFR 820 requirements are meet by following GMP, accurate documentation, and reporting
  • Assist manufacturing, when required, to ensure that quality products are being produced
  • Seek continual improvement with specific suggestions for all inspections
  • Perform process-mapping for Document Control work and recommend areas for streamlining
  • Participate in quality projects, as requested

 

Desired Skillset:

  • Bachelor’s degree preferred, minimum of Associate’s Degree, preferably in quality and/or regulatory discipline
  • 5+ yrs in a similar similar supervisory quality role
  • Prior medical device experience, highly desirable
  • Thorough knowledge of FDA Quality System requirements, ISO 13485
  • ASQ Certification, or equivalent, is desirable
  • Proven ability to supervise, direct, address performance issues, and develop a staff
  • Excellent organizational, verbal, written communication and problem solving skills
  • Possess above-average interpersonal skills demonstrating the ability to work with others in a professional, positive and collaborative manner
  • Ability to work in a fast-paced environment and to meet tight deadlines
  • Willingness to learn, possess a can do attitude, and motivated to succeed and grow
  • Ability to multi-task with strong attention to detail
  • Proficient in MS Office Suite, and of Statistical Process Control Practices
  • Experience working in a start-up environment, helpful
  • Self-driven and highly organized with the ability to work independently and cooperatively in a team setting

 

 

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