Director of Quality Assurance - Active Implantables

Description

• Manage and direct all areas of Quality Control and Assurance within the Active Implants business unit.
• Manage Design & Development Quality and provide strategic direction and oversight for Quality Assurance of medical devices.
• Ensure Design and Development programs are adequately supported for all levels of Design Control (Definition/Concept through Commercialization).
• Review, and contribute to key Design Control and Risk Management deliverables on development programs, such as Quality Plans, Risk Management Plans, Master Verification Plans, Master Process Validation Plans, etc.
• Develop, implement, and maintain required Regulatory compliance with all requisite regulatory agencies, including, but not limited to, U.S. FDA, EU/ISO, Canadian, Asia-Pacific and Latin America regulations.
• Maintain current working knowledge of FDA and global regulatory requirements, and keep senior management apprised of new developments and potential impacts to the customers and the organization.
• Responsible for and leads aspects of the company's ISO and FDA compliance. Interact with Global Regulating Agencies (FDA, Notified Bodies, etc.), respond to requests from regulatory agencies and lead the creation of reports and relevant documentation required to be submitted to the regulatory agencies.
• Design and implement programs, policies, and practices to ensure Quality Assurance, GMP compliance, and lead a quality culture within the organization.
• Manage strategy and approach for all inspection and audits in compliance with local and global regulatory agencies and with customers.
• Provide Quality Assurance oversight of suppliers; prepare and maintain quality agreements. Promote and maintain Certified Supplier programs, including required audits to ensure suppliers are meeting internal and industry standards.
• Manage and lead CAPA, Non-conformance Reporting, deviations, and product complaint investigations.
• Facilitate improvement in quality tools and techniques, including SPC, and provide quality and statistical expertise to cross-functional teams.
• Manage changes in systems or procedures as necessary and provide leadership and act as a change facilitator for key processes such as APC, FMECA, DOE and process validations.
• Develop and manage departmental strategic plans, tactics, and budgets.
• Promote organization to customers globally and fosters customer/industry relations.

• Bachelor of Science, preferably in an engineering discipline (Master's degree or higher preferred).
• Minimum 15 years of experience in a medical device environment, preferably in Quality or Regulatory Affairs.
• Minimum 5 years of experience in management or leadership roles, with supervisory and decision-making responsibilities.
• Experience in managing quality assurance and/or regulatory submissions for Class II and Class III active implant and neuromodulation devices highly desired.
• Quality/Regulatory Certifications such as ASQ CQE, CSSBB / RAPS RAC preferred.
• Must have working knowledge and experience with external standards: ISO 13485, and 21 CFR 820 (FDA cGMP/QSR), especially pertaining to product development, manufacturing, supplier management, quality control and customer complaints.
• Experience in effectively managing and leading audits by customers and regulatory agencies.
• Must be able to implement quality programs, interpret the collected data, and present the data to management to drive continuous improvement.
• Must be able to read, write and speak fluent English.
• Must have strong verbal and written communication skills; ability to present complex data to internal and external contacts.
• Experience in coaching and developing subordinates, utilizing performance management tools, and promoting accountability, employee engagement and retention.