QA Assistant Manager

Job title:                      QA Assistant Manager

Department:               Quality

Reports to:                  Corporate Director

HR approved:             Mar 2019


Position Summary:

The desired candidate will have prior “hands on” people management experience in Quality, preferably working in a medical device company. Specific experience and responsibilities will include, but not limited to: people management; organize and direct workload; create and monitor employee goals; provide constructive feedback; conduct performance reviews; create, monitor, and report metrics to both team and management; conduct weekly team meetings; and assist in inspections and documentation control, as required. Candidate will be energetic, responsive, highly accountable, exhibit strong personnel management, be well-organized, ultimately leading a team that promotes patient safety and customer satisfaction, and that positively impacts the goals of the organization.


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 with direction from department manager 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
  • Ensure all calibration and measurement tools are in working order
  • Monitor and verify that First Article inspections are conducted per customer requirements
  • 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 21 CFR 820 requirements are meet by following GMP, accurate documentation, and reporting
  • 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 people management role in Quality
  • 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, ERP System (NetSuite); Electronic Doc Control Systems (MasterControl; DocStar)
  • 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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