VP of Quality Assurance & Regulatory

The VP of Quality Assurance and Regulatory Affairs will be the point person for key decisions and guidance in both quality assurance and regulatory affairs and will ensure that the Company is conducting its processes, process improvements, and ultimate regulatory submissions in the most accurate, prudent, and efficient way possible. 

Responsible for overseeing and augmenting the Quality Assurance department while supporting the development of the Quality Management System, which includes but is not limited to Design Controls, Supplier Management, post market surveillance activities (i.e. complaint investigations). Supports R&D teams with respect to Design Controls, Risk Management, and Quality. Responsible for understanding and ensuring company objectives are in line with applicable regulatory standards, such as ISO, MDR, and the Quality System Regulations. Leads the Regulatory Affairs department while ensuring that regulatory documentation to predetermined markets is appropriately addressed (e.g. PMA supplements, 510(k) submissions).

Responsibilities:

• Manages Regulatory and Quality department and overall expectations pertaining to setting accurate schedules, costs, and resources.
• Ensures department is adequately resourced and trained to perform jobs effectively.
• Supervises Regulatory and Quality staff including coaching and developing to enable maximum performance and individual employee growth, providing regular performance review and feedback and using corrective action as necessary.
• Maintains Company compliance of FDA Quality System Regulations and ISO standards and other international regulations, as applicable.
• Supports Investigation Device Exemption (IDE), Feasibility Studies, Pivotal Studies and Pre-Clinical studies.
• Leads regulatory submission planning and document writing activities.
• Manage and supports Design Control activities.
• Develops inspection and process control procedures up to the design transfer stage, and ensures optimal design transfer to manufacturing through collaboration with Operations and Quality Assurance.
• Maintains product consistency throughout product cycle, to include the design, define, and build phases through quality checkpoints and testing.
• Provides necessary definition, development, and deployment of product quality assurance strategy, addressing all phases of product development.
• Prepare and maintain technical files as necessary to obtain and sustain product approval (e.g. 510(k) submissions, PMA supplements, technical files).
• Participates in Risk Management activities during the development and transfer of manufacturing processes.
• Provides oversight, guidance, and assistance in Supplier Management activities, such as supplier evaluation, monitoring, and auditing.
• Assists in the Company’s complaint, failure, nonconformance, and CAPA investigation processes.
• Manages protocol and report development for pre-production activities.
• Develop and maintain productive and effective relationships with subordinates, peers, and superiors.
• Demonstrate a high standard of work ethics and professionalism to subordinates, peers, and superiors at all times.
• Represent the company in a positive and supportive manner at all times.
• Performs special projects and other duties as assigned.

Required Qualifications:

• Bachelor’s degree in Engineering, Quality Assurance or related discipline.
• Minimum of twelve (12) years experience in quality assurance, engineering and/or regulatory affairs with a medical device and/or pharmaceutical manufacturing company.
• ASQ CQE certification preferred.
• Must have DOE, Statistical Analysis, Quality System implementation, Quality Engineering Techniques, IQ/OQ/PQ, QSR (GMP) and ISO experience. Knowledge of basic statistical and engineering principals is essential.
• Experience with US FDA and international submissions.
• Excellent problem solving, interpersonal communication, presentation, statistical analytical, computer, and project management skills.