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As Director of Design Quality, you will ensure the highest quality design and development of our Advanced Surgery products including hemostats, sealants, tissue repair, and adhesion prevention. You will lead a team, develop comprehensive strategies, establish design quality metrics, and ensure alignment with industry standards and regulatory requirements. This position requires creativity, attention to detail, and strong leadership in a complex and critical field of healthcare.
Job Responsibility:
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.
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.
What we offer:
Support for Parents
Continuing Education/Professional Development
Employee Health & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
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