Vice President of Quality – Medical Device

Retained Search – Hybrid Position

Position Overview: Responsible for overseeing and managing the quality function and all aspects of quality. Establish and maintain a robust quality management system, processes, and procedures to ensure compliance with applicable health authority regulations, guidelines, and standards. Represent quality on the management board/leadership team. Serve as the primary point of contact for quality-related matters during regulatory inspections, audits, and customer inquiries.

Responsibilities:

• Develop and implement a comprehensive quality strategy and roadmap aligned with business objectives and regulatory standards.
• Develop and implement the Quality Goals and Objectives.
• Develop the quality budget.
• Collaborate closely with cross-functional teams, including R&D, manufacturing, regulatory affairs, and supply chain, to ensure seamless integration of quality standards throughout the product life cycle.
• Oversee the supplier quality and third-party oversight program, including audits to identify potential quality issues, deviations, or non-conformities, and implement appropriate corrective and preventive actions.
• Stay abreast of evolving regulatory requirements and industry trends to proactively identify process improvement and innovation opportunities.
• Foster a quality and continuous improvement culture by organizing training programs, workshops, and knowledge-sharing initiatives.
• Lead management review. Serve as the management representative. Chair the Quality Board; holds the responsibility for market actions.
• Responsible for Post Market and Complaint Vigilance.
• Responsible for the Quality Aspect of Design Control.
• Lead continuous improvement initiatives, implement digital quality strategies, and drive simplification of processes.
• Driving quality culture.
• Responsible for company-wide training.
• Ensure quality strategy is aligned with business needs and integrated into company goals and objectives.
• Monitor quality skills and capabilities as the business evolves.

Requirements:

• Bachelor’s degree in science or engineering with 15+ years of experience in medical devices or Master’s degree with 12+ years of experience in medical devices.
• Deep working knowledge of quality systems and compliance.
• Demonstrated success in leading and managing a team of quality assurance professionals, providing guidance, coaching, and performance evaluations.
• Experience hosting and facilitating regulatory inspections and skilled in interacting with government officials.
• Strong technical judgment and advanced leadership skills.
• Strong risk management skills.

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