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As Director of Design Quality, you will ensure the highest quality design and development of Advanced Surgery products including hemostats, sealants, tissue repair, and adhesion prevention. The role involves leading a team, setting priorities, and driving continuous improvement within the quality systems while collaborating cross-functionally and staying ahead of industry trends.
Job Responsibility:
Lead a team of Design Quality professionals responsible for product development, lifecycle management activities, and post-market monitoring
Develop and implement comprehensive design quality strategies
Set and lead priorities within the team based on strategies and business needs
Establish and maintain design quality and key performance indicators, conducting regular reviews and analyses
Drive continuous improvement initiatives
Serve as subject matter expert on design quality matters
Provide expertise and support to cross-functional teams and external partners
Partner with Quality System element stewards to develop, maintain, and improve the Quality System
Stay abreast of industry trends, new technologies, and regulatory changes
Incorporate insights into strategies and initiatives
Represent the company in industry forums, conferences, and standards committees
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
Nice to have:
Conflict resolution skills
Persuasive management techniques
What we offer:
Medical and dental coverage starting on day one
Basic life insurance
Accident insurance
Short-term and long-term disability insurance
Business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan with company matching
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service
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