Director of Quality & Regulatory Affairs

Massachusetts | Quality Assurance / Safety

Director of Quality and Regulatory Affairs

Our client is a successful, multi-national Contract Manufacturer to Medical Device companies.  They have engaged us to find exceptional talent for this Director level role that has responsibility for the QS and RA in several facilities across the US.  The qualified candidate will direct the facility’s quality managers who are responsible for compliance to ISO 13485 and 21 CFR 820 in a matrix style organization.

As the champion for Quality; training, auditing, reporting results of Quality KPI’s and generally providing for a culture of Quality will all be in your scope of responsibility.  Planning, management, coaching and mentoring all need to be innate to your style as they’ll be used on a daily basis.  Your Regulatory knowledge will also be crucial as you may interact directly with FDA or be responsive to them (or other notified bodies) pursuant to client needs or the company’s FDA Registration.  While these facilities do not produce finished devices, the products they manufacture are mass-produced, critical components of devices and therefore may impact patient safety. 

Responsibilities:

  1. Responsible for adherence of divisional Quality Systems to the corporate Quality Manual, conformance to regulatory requirements of notified bodies (e.g. FDA, EU), meeting the needs of client’s systems and providing for ongoing ISO, FDA and other certifications or registrations
  2. Directs the activities of Divisional Quality Managers in a manner concurrent to the needs of the facility’s production targets and the corporation
  3. Uses/Teaches/Implements Risk Management tools (e.g. Lean/Six Sigma) to anticipate the needs of the business units regarding capabilities, capacities, quality trends, NPD challenges, and the changing regulations landscape
  4. Confirms that the requirements of Design Control are provided for and complied to
  5. Maintains a focus on the effectiveness of the QS to the client base and the employer, and to conforming product delivered in a timely fashion that contributes to the financial wellbeing of the business
  6. Safeguards the accuracy of the QS, making sure that additions, updates, or wholesale changes are documented and that subsequent training is provided as needed
  7. Develops and/or uses a Quality Dashboard to ensure that all locations are timely in their response to CAPA’s both internal and external, or other Quality needs e.g. Customer Complaints, or FDA letters
  8. Stays current to the Regulations landscape, interpreting their impact on the corporation for the purpose of keeping executive management informed and ensuring that divisional Operations and Quality management are trained on how the changes may affect them
  9. Works with peers and the executive management team to confirm the ongoing effectiveness of policies, procedures, and objectives
  10. Is an effective conduit of information, making sure all levels of the Quality organization are in tune with management direction and objectives for the purpose of assisting to achieve those goals

Requirements:

  • BS in an Engineering discipline or other technical degree (MS preferred)
  • Demonstrable knowledge of and experience in ISO 13485, 14971, 21 CFR 820 and/or other notifying bodies
  • A minimum of 10 years’ experience in quality (OEM and/or Contract Manufacturing) where at least 5 of those are in a regulated environment, with an additional 3+ years in management; strongly prefer multiple location experience
  • Computer skills in MS OfficeÒ and tools like Project™, CAD (e.g. SolidWorks), and MRP or ERP systems
  • Experience in, or demonstrable knowledge of Plastic Molding/Injection Molding is highly valued
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