Overview

Position Summary:

Seeking a highly-motivated Director of Quality Assurance to join our fast-growing team. My client is a medical device manufacturing company for class II and III devices looking to hire a Director of Quality, Medical Device to add technical depth to their team. This position reports into a C-Suite executive and is a highly autonomous role.

Key Activities:

  • Maintain and improve Quality Management System to ensure compliance with worldwide medical device regulations and standards and to improve operational effectiveness
  • Serve as the subject matter expert on applicable health agency regulations and industry best practices on Quality Systems and Product Quality
  • Maintain and improve a compliant and effective risk-based product and process lifecycle validation program including design controls, risk management, design and process verification and validation, change control, and continuous process monitoring
  • Manage product & patient risk to ensure effective management and control of product/process deviations for all released product and for the implementation of effective corrective action when non-conformances arise
  • Develop and implement a pipeline of quality improvement activities including initiatives to increase product quality, NCR & CAPA resolution, reduce cost, decrease inefficiencies and improve risk management
  • Ensure all corporate sites maintain continued certification to all regulatory bodies, playing a lead role in all internal and external audit programs including corporate, notified bodies, and regulatory agencies (FDA, CFDA, ISO, etc.)
  • Ensure regulatory compliance of clinical activities to demonstrate safety and efficacy of company materials and devices, and lead global product registration activities

Required Qualifications:

  • Broad experience in Operations, Quality, and Product Development preferred.
  • BS in a technical field required, advanced degree preferred, Quality certification preferred
  • Minimum of 12 years’ experience in Medical Device Industry with an in-depth understanding of medical device product lifecycle
  • Demonstrated knowledge of Quality Management Systems and experience linking risk management to all elements of the Quality System (Design Controls, CAPA, Change Management, Complaints, Document Control, etc.)
  • Strategic view in identifying global alignment and developing strategies for best in class practices and benchmark against industry leads and regulatory requirements for the Quality function.
  • Demonstrated success creating and managing talented, engaged, and performing team
  • Ability to implement organization and functional strategy. Ability to initiate and implement change with a demonstrated track record of success
  • Expert working knowledge of regulatory requirements, standards and regulations, with experience of managing inspections/audits by the FDA and other regulatory and notified bodies