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Director, Design Quality

https://www.baxter.com/ Logo

Baxter

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Location:
United States, Deerfield

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Category:
Quality Control

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Contract Type:
Employment contract

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Salary:

176000.00 - 264000.00 USD / Year

Job Description:

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
  • Employee Stock Purchase Plan (ESPP)
  • 401(k) Retirement Savings Plan
  • Flexible Spending Accounts
  • Educational assistance programs
  • Paid holidays
  • Paid parental leave
  • Commuting benefits
  • Employee Discount Program
  • Employee Assistance Program (EAP)
  • Childcare benefits.

Additional Information:

Job Posted:
March 20, 2025

Employment Type:
Fulltime
Work Type:
On-site work
Job Link Share:
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