Director of Quality, Medical Device

Reference Number: 478
Location: NJ

Director of Quality

Our client is a services leader in the Medical Device space providing customers with solutions from components to assemblies and including packaging.  The qualified candidate will be highly disciplined, have a strong work ethic driven by the desire to ensure that only quality product leaves the facility but also having the common sense to discern between real and imagined issues.  The environment is fast-paced, pro and reactive, hands-on at every level and intense. 

The Director reports to the President and is an active member of the Executive Management team.  S/he is responsible for the QS in its entirety from certification/maintenance/improvement of the 13485 Standard to occasional audits on the FDA registration.  Process from Validation to Verification, including capability, control and DOE’s are highly valued strengths as is a background in the application and use of SPC.  Notwithstanding the importance of the technical skill-set, the soft skills of communications, leadership, mentoring and coaching are equally valued. 

RESPONSIBILITIES

  1. Establishes a culture of Quality where Assurance drives process and Control confirms results through published performance to metrics that are used to drive improvement and reduce cost
  2. Develops the Quality operations’ goals and objectives, and SOP’s in compliance with ISO 13485 & FDA 21 CFR 820 (and other bodies as required) that result in the highest standards for quality product delivered to the client and contribute to the company’s financial performance
  3. Manages and coordinates cross-functional activities supporting manufacturing and development efforts on all products, legacy and new
  4. Champions compliance and continuous improvement with equal attention demonstrating the value of “do what you say” while recognizing the need for adaptability and improvement
  5. Regularly interacts with client Quality Teams keeping the company’s QS aligned to the client’s needs without impairing re-certification
  6. Defines departmental personnel strategy providing for the individual growth of direct reports through training and certifications appropriate to the company’s needs and growth
  7. Provides support, direction and coaching to subordinate employees including hiring, evaluation, training, and disciplinary action
  8. Manages, coordinates and implements the auditing process both internally and externally
  9. Interacts with certifying bodies and FDA regarding compliance issues directly effecting the company’s operations
    1. Provides regular feedback to the executive team and others on compliance with and performance to SOP’s, e.g. CAPA, Material Disposition, Returns, etc. 

REQUIREMENTS

  • Bachelor’s degree in Engineering or other appropriate discipline; technical Master’s degree a plus; ASQ certifications a plus
  • 15 years’ experience where at least 5 years are in a management role and at least 5 years are in Medical Device manufacturing
  • Verifiable experience in ISO 13485 and cGMP’s required; ISO 14971 a plus
  • Demonstrable experience in device manufacturing at the component and/or assembly level
  • Strong background in ALL functions of a QS including but not limited to Assurance, Control, Compliance, & Design
  • Experienced in the 1st chair during certifying body and/or FDA audits
  • Strong knowledge-base in SPC
  • Experience in a wide range of metals manufacturing techniques; experience with plastic a plus
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