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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. You'll lead a team of professionals, develop strategies, and collaborate with teams to achieve Baxter's mission of saving and sustaining lives.
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
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.
Nice to have:
Advanced degree
knowledge of worldwide regulatory requirements and industry standards
experience with biologics and combination product development.
What we offer:
Medical and dental coverage starting on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan
401(k) Retirement Savings Plan with options for employee contributions and company matching
Flexible Spending Accounts
educational assistance programs
paid holidays and paid time off ranging from 20 to 35 days based on length of service
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