Senior Quality Assurance Engineer

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. Youll also have access to:

• Career development with an international company where you can grow the career you dream of.

• Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical 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 bachelors 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 Youll 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

• Bachelors 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 crossfunctional leadership skills.
• Ability to manage multiple priorities in a complex fastpaced 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

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

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Senior IC