Director, Product & Supplier Quality - Medical Devices (858)
Finnesse Partners LLC - Minneapolis, MN

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We’ve been engaged by our client to recruit their Director, Product & Supplier Quality . This medical device company is looking for a strong manager who can l ead operational quality business development strategy and e xecution in the areas of material receipt and QC, in-house manufacturing, contract manufacturing and supplier quality management . Ideal candidates will have 15+ years of product quality and supplier quality experience in the medical device industry, including 5 years management experience of engineers or other technical staff . Candidates must have experience with medical consumable/disposable products.

Responsibilities:
  • Work collaboratively throughout the organization to promote best-in-class quality of commercialized products, ensuring product performance and reliability while minimizing waste.
  • Ensure product and processes meet or exceed defined performance and customer requirements as well as applicable quality system requirements and external standards.
  • Utilize best practices and continuous improvement principles wherever possible.
  • Provide leadership with strategic insight, directing and implementing all quality engineering activities related to the existing commercialized product and product improvement, in alignment with the corporation vision of device portfolio management.
  • Take ownership of all aspects of commercialized product quality, using sound judgment to make important and difficult decisions that may involve science and engineering, business risk management, and knowledge of healthcare and product-use environment, using all available sources of internal and external information including customer product experience.
  • Drive continuous improvement of product quality and reduction of waste.
  • Oversee manufacturing quality operations, including subcontracted processes, internal production, and test processes / release.
  • Participate and in some cases lead forums related to quality metrics, cost of quality, master validation plans, QC inspection / release, nonconforming material, complaint investigations, process FMEA and change control. Establish and maintain a supplier quality management process that ensures product reliability and performance while reducing waste and controlling costs.
  • Participate with head of operations to establish strategic supplier plans and objectives, making decisions on supplier quality matters and ensuring quality operations’ effective achievement of objectives.
  • Manage continuously the supply chain performance of component providers to company production facilities and participate on the supplier review board.
  • Report to senior management on all quality aspects of supply chain management from supplier evaluation and performance to finished goods testing and release, in a manner that drives continuous product improvement.
  • Responsible for management of incoming inspection process, nonconforming material process, and final product release.
Requirements:
  • B.S. degree in Engineering or other science discipline
  • 15+ years product quality and supplier quality experience in the medical device industry or in combination with other highly-regulated environments
  • 5 years management experience of engineers or other technical staff
  • Demonstrated success in the coaching, development and overall leadership of a committed, well-aligned team that delivers results.
  • Thorough knowledge of process validation, statistical method and analysis, and risk management
  • Innovative thinker and problem solver; brings a big-picture perspective – the ability to see how all the pieces fit together and contribute to the achievement of broader organizational objectives; strong business acumen and judgment.
  • Moderate or strong knowledge in at least several areas pertaining to controlled environments, packaging, sterilization, cleanliness/wash processes, plastics such as molding, extrusion and bonding, and electromechanical devices with embedded software/firmware.
  • Strong technical knowledge and problem solving skills.
  • Travel requirements are moderate. Travel to facilities would be about 2 – 3 days duration each trip with total travel expected to be less than 20%.
  • Ability to develop clear, concise, and timely oral and written reports.
  • Excellent interpersonal and communication skills to organize and negotiate with multi-disciplinary teams and with different levels of personnel.
Preferred:
  • Six Sigma or Operational Excellence knowledge or certification.
  • Demonstrated project management skills in order to plan, conduct and implement system assessments.
  • Direct experience with regulatory auditors such as ISO and FDA
  • Demonstrated knowledge of business processes and interactions with executive management

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