Director, Quality

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

WORKING AT ABBOTT:

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.

THE OPPORTUNITY:

This role leads 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.

WHAT YOU’LL WORK ON:

• 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 and notified bodies.
• 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. Leverage analytics and KPIs to proactively identify risks, drive timely decisions, and protect patient safety and product quality
• Lead development and continuous improvement of a risk-based QMS, including digital and AI-enabled capabilities, ensuring scalability, compliance, and alignment to business needs. Translate quality strategy into execution, driving first-time quality, operational excellence, and proactive risk mitigation across the organization.
• Talent development and management, organizational development Build high-performing teams and foster a strong quality culture through coaching, development, and executive influence across stakeholders.
• 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
• Manage quality budgets, including planning and optimization of Notified Body activities and spend.

QUALIFICATIONS:

• Bachelor's degree. Degree in Microbiology is 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.

APPLY NOW:

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.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal

The base pay for this position is

$172,000.00 – $344,000.00

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

JOB FAMILY:

Operations Quality

DIVISION:

CRM Cardiac Rhythm Management

LOCATION:

United States > Sylmar : 15900 Valley View Court

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf