VP of Quality
DUTIES AND RESPONSIBILITIES:
- Develops and implements quality system procedures to ensure compliance to applicable industry standards and regulations such as Quality System Regulation 21 CFR Part 820, ISO 13485, and the European Union’s In Vitro Diagnostic Regulation. May include other international regulations as applicable. Understands that while external quality requirements are important, they are not necessarily sufficient; driven to improve quality each day.
- Supports compliance audits/inspections by certification bodies and regulatory authorities. Trains subject matter experts and other personnel in dealing with certification/regulatory authorities.
- Manages the internal auditing program to ensure continued compliance and report compliance status to the executive management team. Oversees management of equipment records and ensures all equipment is on proper maintenance and calibration schedule.
- Manages the Non-Conforming Material, Deviation, and CAPA Systems. Serves as Management Representative for Quality and Person Responsible for Regulatory Compliance (PRRC) for Quality-related items.
- Manages quality engineers & technicians supporting research & development, design transfer, and commercial operations.
- Manages the QC Test Lab ensuring compliance with regulatory requirements through quality system procedures while performing product testing to support design transfer, production, and stability monitoring schedules.
- Manages document control ensuring compliance with regulatory requirements through quality system procedures while supporting timely release and revision of controlled documentation, standards maintenance, and training program.
- As a member of the executive team actively contributes to and participates in key company decisions. Works hard to develop and maintain a cohesive executive team. Is totally bought in to achieve the mission and to fulfill the company’s outrageous growth expectations.
- Collaborates with product development teams to successfully transition new products to operations.
- Leads efforts to solve problems, address customer complaints, and improve not just product quality but the quality of the customer experience.
- Recruits, selects, on-boards, trains and retains qualified personnel in all positions in the quality function. Always working to make the team function and perform better.
- Monitors supplier quality. Understands how important the supplier team is to delivery, quality, and product cost and is committed to continuous improvement of supplied materials.
- Develops, modifies, improves and reports company-wide metrics as a part of an ongoing performance improvement program.
- Develops, reviews, endorses and complies with functional budgets.
- Collaborates with other departments in carrying out all responsibilities. Successfully builds relationships across functions at multiple levels within operations.
EDUCATION AND EXPERIENCE REQUIRED:
- Bachelor’ Degree or greater in a scientific field
- 10+ years’ experience in manufacturing environment, 5+ years in a senior quality management position.
- Expert knowledge of medical device regulations, standards, current industry practices, and strong experience with interpretation and application. Experience with hardware/software medical devices.
- Strong problem solving, communication skills and project management skills required
- Experience with all phases of the product development lifecycle, including concept, design, implementation, verification and validation activities necessary for product commercialization.