Director Quality Assurance

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 114,000 colleagues serve people in more than 160 countries.

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JOB DESCRIPTION : Working at Abbott

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.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• 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 position works out of our Pomona location in the Cardiometabolics division.

As the Director, Quality Operations, you will develop, establish and maintain operational quality assurance programs, policies, processes, procedures and controls ensuring that the organization conforms to established standards and agency regulations.

What You’ll Work On

• Acts as Site Management Representative with overall site responsibility to establish an effective and compliant Quality System that meets changing regulatory requirements and business needs.
• Provides overall leadership for Quality policies, approaches, and standard practices. Maintains alignment with US and International regulations and standards, as well as Abbott quality systems.
• Supports operations in continuous improvement initiatives by providing direction on process validation / verification requirements for proposed changes.
• Provide overall functional Quality leadership which may include : Supplier Quality Assurance and Operations Quality.
• Support New Product Initiatives as a Core Team Member supporting design control and design transfer projects.
• Assures Quality provides technical support and services to Operations and Research & Development functions.
• Identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.
• Be a champion of Quality, Lean and disciplined problem solving throughout the organization.
• Demonstrates effective change leadership by building strategic partnerships across functional areas, business units and geographies.
• Support all Divisional initiatives as identified by management.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Communicates strategic direction, quality policies / procedures and effectiveness of the Quality system to the organization.
• Directs and controls the activities and budget of site QA functional operations.

Required Qualifications

• Bachelor’s Degree in Life Sciences or Engineering.
• Minimum of 10 years of related work experience in IVD, Medical Devices / Pharma / Biotech organization with at least 5 years in a Quality Assurance / Operations / R&D site leadership role.
• At least 3+ years management with demonstrated compliance excellence, value improvement, risk reduction, and cost containment.
• Strong leadership skills with demonstrated ability to create momentum and deliver excellent results.
• Strong organization, speaking skills, and influential management ability.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to set goals and provide positive and constructive feedback respectfully.

Preferred Qualifications

• Master’s Degree or MBA.
• Class III or II medical device background.
• Ability to travel approximately 25%, including internationally.
• Conducting root cause analysis on highly technical problems.

Apply Now

Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

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.

JOB FAMILY : Operations Quality

Operations Quality

DIVISION :

CMI ARDx Cardiometabolic and Informatics

LOCATION : United States >

United States >

Pomona : 821 Towne Center Drive

WORK SHIFT : Standard

Standard

TRAVEL :

Yes, 25 % of the Time

MEDICAL SURVEILLANCE :

Not Applicable

SIGNIFICANT WORK ACTIVITIES :

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

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