Senior Quality Assurance Engineer

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 your 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 in the next calendar year.
• An excellent retirement savings plan with a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

The Senior Supplier Quality Assurance (SQA) is responsible for developing and executing supplier quality strategy, ensuring compliance with global regulatory requirements, and improving supplier performance across a diverse supply base. This role leads supplier auditing, qualification, risk management, and issue resolution, partnering closely with Procurement, R&D, Manufacturing, Regulatory Affairs, and other departments within the quality organization. This role will also learn to balance supplier requirements between medical device and consumer businesses. The individual will serve as the primary escalation point for critical supplier issues and supports major regulatory inspections across the business.

What You'll Work On

• Lead supplier quality assurance activities to ensure compliance with internal quality standards and applicable regulations, including ISO 13485, FDA QSR, MDR/IVDR, and other global requirements.
• Own supplier onboarding, qualification, and requalification processes, including supplier risk assessments, quality agreements, documentation review, and Approved Supplier List maintenance.
• Plan and execute supplier audits and assessments (remote, desktop, and on-site), identify systemic gaps, and drive timely, sustainable corrective and preventive actions.
• Monitor and improve supplier performance through dashboards, KPIs, trend analysis, and targeted improvement initiatives across the supplier base.
• Partner cross-functionally with Procurement, R&D, Manufacturing, Regulatory Affairs, and other stakeholders to resolve supplier-related quality issues and ensure effective root cause investigation and resolution.
• Evaluate supplier changes and quality events, including nonconformances, SCARs/CAPAs, complaints, and supplier-requested changes, to ensure appropriate risk assessment, containment, and long-term corrective action.
• Provide strategic quality input into supplier selection and sourcing decisions to support quality, regulatory, risk management, and business continuity objectives.
• Support supplier capability development by promoting best practices in qualification, validation, process controls, and continuous improvement.
• Serve as the primary escalation point for critical supplier quality issues, coordinating rapid response, leadership communication, and issue resolution.
• Maintain inspection-ready documentation and support regulatory audits, including supplier files, audit reports, risk assessments, qualification records, and closure of supplier-related audit findings.
• Contribute to quality system harmonization and policy updates to ensure alignment with corporate quality requirements and evolving global regulatory expectations.

Required Qualifications

• Bachelor's degree in engineering, Life Sciences, Quality, or related technical field or equivalent combination of education experience.
• Minimum 2 regulated environment such as medical devices, pharmaceutical products, food manufacturing, aerospace, or automotive.
• Minimum 5 years Supplier Quality, Quality Engineering, Supply Chain Quality, or applicable industry experience, and demonstrated use of Quality tools/methodologies
• Some working knowledge of ISO 13485, FDA QSR (21 CFR 820), ISO 14971, and MDR.
• Demonstrated experience participating in, conducting, or leading supplier audits (remote and onsite).
• Proficiency in root cause analysis, CAPA management, risk analysis, and supplier issue resolution.
• Some knowledge of supplier qualification, risk management, and process validation (IQ/OQ/PQ).
• Demonstrated ability to present supplier performance metrics, dashboards, and improvement recommendations to leadership.
• Strong communication and cross-functional leadership skills.
• Ability to manage multiple priorities in a complex, fast-paced environment.
• Ability to travel up to 10% annually, both nationally and internationally.

Preferred Qualifications

• Advanced degree (MS, MBA) or professional certifications (ASQ CQA, CQE, CSQP, Six Sigma Green/Black Belt).
• Direct experience in medical device manufacturing or another highly regulated environment.
• Experience with PPAP, FAI, PFMEA, Control Plans, and supplier process controls.
• Experience with MDF/DHR/DMR
• Prior experience leading or supervising Supplier Auditors.
• Experience with supplier development, process capability improvement, or operational excellence projects.
• Experience working with global suppliers

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

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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The base pay for this position is
$90,000.00 - $180,000.00
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:
Operations Quality


DIVISION:
LNGO Lingo


LOCATION:
United States > Alameda : 2901 Harbor Bay Parkway


ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard


TRAVEL:
Yes, 10 % of the Time


MEDICAL SURVEILLANCE:
No


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)


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


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