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Director of Quality Assurance

Dallas, Texas | Quality Assurance / Safety

Director of Quality Assurance

 

Our medical device client is in the enviable position of experiencing growth and exciting change.  The Dir. QA reports to the VP QA/RA who is “looking for people that can manage up and communicate to management as well as someone who can lead others.  Personality fit is really important; I’m looking for a dynamic personality.  Someone who can garner buy-in, get the resources they need, train, inspire, and be a leader.” 

 

The Dir. QA is responsible for the breadth of the Quality organization, is a team-builder, and solutions oriented.  The VP wants the Director to be entrepreneurial and make the department their own so the VP can lean on their expertise.  The candidate needs to be able to see the ‘fear’ of change but embrace the risk of it because the Quality organization is in the midst of change.  Experience in Medical Device Quality Management is an absolute must for this position. 

 

RESPONSIBILITIES:

  • Responsible for the QMS, ensuring compliance to the requirements of notified bodies, specifically maintaining conformity to the requirements of ISO 13485, 21 CFR 820 and other medical device quality standards
  • Works in close relationship with the Dir. RA to foster departmental alignment, as well as provide for an environment of collaboration
  • Constantly assesses the QMS for opportunities to improve process and product, e.g. will champion and lead the transition to an electronic QMS
  • Provides thoughtful strategic direction to the breadth of the Quality group, providing training and direction on objectives while supporting Corporate direction
  • Works with management and within budgetary requirements to establish an organizational structure for Quality
  • Leads by example of transparency and responsibility, developing a cross-functional culture of Quality that guarantees patient safety
  • Actively contributes to budget planning, preparing for short-term and future resource requirements in human, material, and capital expenditures
  • Leads the breadth of Quality functions to improve process/product variation (Cpk), ensure all products meet specifications, reduce risk to the patient and the company, and stay compliant to ISO and the cGMP’s
  • In collaboration with RA, stays abreast of changes to standards; assessing and identifying gaps, then implementing required changes to maintain compliance
  • Provides personnel with developmental opportunities specifically identifying key contributors and mentoring them as successors to open opportunities across the organization

REQUIREMENTS: 

  1. BS in Engineering or other appropriate technical discipline (MS highly valued)
  2. 10 + years in the Medical Device industry where at least 7 of those are in Quality
  3. Minimum of 5 years’ experience in Quality Management
  4. ASQ certifications, e.g. CQE/CSSBB preferred
  5. Demonstrable expertise in ISO 13485/21 CFR 820 systems with experience in Classes I, II, and III
  6. Successful creation and implementation of a QS
  7. Experience with implantable devices and their manufacturing processes preferred, knowledge of biomaterials highly valued
  8. Extensive background in process validation & capability, experienced with statistical process measurement and analysis, and knowledgeable in Lean/Six Sigma
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