Director – Design Quality – Advanced Surgery

Director – Design Quality – Advanced Surgery

Requirements

• Bachelor’s in engineering, science, or related field required; Advanced degree preferred.
• 10+ years of experience in quality, engineering, or a related product development function, 7+ years of managerial experience.
• Detailed understanding of the medical device, biologics, and combination product development cycle, knowledge of worldwide regulatory requirements and industry standards.
• Significant breadth and depth in quality decision-making, risk management, and quality engineering.
• Conflict resolution skills including persuasive management techniques required.

Responsibilities

• Lead a team of Design Quality professionals who are responsible for product development, lifecycle management activities, and post-market monitoring.
• Develop and implement comprehensive design quality strategies, ensuring alignment with company goals, industry standards, and regulatory requirements. Set and lead priorities within the team based on these strategies and business needs.
• Establish and maintain design quality and key performance indicators, conducting regular reviews and analyses to drive continuous improvement initiatives.
• Serve as a subject matter expert on design quality matters, providing expertise and support to cross-functional teams and external partners.
• Partner with Quality System element stewards to develop, maintain, and improve the Quality System in relevant areas.
• Stay abreast of industry trends, new technologies, and regulatory changes, and incorporate relevant insights into strategies and initiatives.
• Represent the company in industry forums, conferences, and standards committees, sharing knowledge to the advancement of the medical device industry.

Preferred Qualifications

• Advanced degree preferred.