Director, Quality

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan.
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

This role with lead CRM global Quality System Management and Audit, as well as CRM global Microbiology & Sterilization oversight, including direct oversight of the Sylmar Microbiology/Sterilization based team and operation for production manufacturing.

• Organizing, hosting, and executing regulatory audits across the global CRM network. Develop and drive audit strategies and plan across CRM global network/sites, in alignment with increasing complexity from global regulatory agencies.
• CRM network microbiology and sterilization oversight, as well as direct leadership responsibility over Sylmar based micro/sterilization team and production operation. Drive sterilization acceptance approaches / compliance with appropriate standards across the CRM global manufacturing network.
• Quality Management System (QMS) evolution, upkeep, and compliance. Develop and drive strategies for implementation of Quality tools, demonstrating acceptability within the quality system.
• QMS supplier management, modernization of QMS tools
• Continuous improvement, upkeep with evolving global regulations, and modifying QMS (particularly in the advent of AI applications to product offerings and within QMS execution)
• Talent development and management, organizational development, budget management
• Direct work with FDA and other geographic regulators to enable continued good standing of the CRM business to enable unincumbered launch cadence of new product iterations into the market

• Bachelor's degree. Degree in Microbiology highly preferred.
• 15 years of experience within engineering, quality, microbiology, or related experience. In-depth knowledge and experience required in medical device regulated businesses, specifically in hosting regulatory audits; additionally expertise in microbiology and medical device sterilization techniques.

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Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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In specific locations, the pay range may vary from the range posted.