AbbottSenior Supplier Development Quality 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 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 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
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 sustaining Supplier Quality teams. 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
- Drive supplier quality assurance initiatives to ensure full compliance with internal quality standards, ISO 13485, FDA QSR, MDR/IVDR, and global regulatory requirements.
- Coach and mentor Supplier Auditors, ensuring consistency, competency, and effectiveness in supplier audit execution.
- Plan and conduct supplier audits and assessments (remote and on‑site), identify systemic gaps, and lead cross‑functional teams to implement robust and sustainable corrective and preventive actions.
- Drive and implement supplier quality process improvement initiatives, including enhancements to supplier qualification, ongoing monitoring, and periodic re‑evaluation processes.
- Develop and maintain supplier performance dashboards and KPIs, analyze trends, and provide insights and recommendations to leadership.
- Lead supplier risk assessments and ensure risk‑based prioritization of audits, controls, and monitoring activities.
- Collaborate with Procurement, R&D, Manufacturing, and Regulatory Affairs to resolve supplier‑related issues, ensuring timely root cause analysis and sustainable solutions.
- Manage HF supplier‑related CAPA activities, including initiation, investigation oversight, verification of effectiveness, and timely closure.
- Lead supplier onboarding and qualification activities, including risk assessments, quality agreement execution, and review of supplier documentation (e.g., ISO certifications, process controls, inspection protocols).
- Provide strategic input during supplier selection and sourcing decisions to ensure alignment with quality, risk, regulatory, and business‑continuity requirements.
- Champion continuous improvement across the supplier base, including training, capability building, and implementation of best practices.
- Ensure alignment with corporate quality policies and global regulatory expectations and contribute to QMS policy updates and harmonization initiatives.
- Act as the primary escalation point for critical supplier quality issues, facilitating rapid containment, communicating status to leadership, and coordinating resolution.
- Support internal and external regulatory audits (e.g., FDA, Notified Body), prepare required documentation, support audit interviews, and ensure timely closure of supplier‑related findings.
- Maintain accurate and compliant documentation, including audit reports, supplier files, CAPA records, qualification packages, and supplier risk assessments.
Required Qualifications
- Bachelor’s degree in engineering, Life Sciences, Quality, or related technical field or equivalent combination of education experience.
- 8+ years of experience in Supplier Quality, Quality Engineering, or Supply Chain Quality in a regulated industry (medical devices strongly preferred).
- Demonstrated experiencer mentoring junior engineers .
- Strong working knowledge of ISO 13485, FDA QSR (21 CFR 820), ISO 14971, and MDR.
- Demonstrated experience conducting and leading supplier audits (remote and onsite).
- Proficiency in root cause analysis, CAPA management, risk analysis, and supplier issue resolution.
- Experience with 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 40% 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.
- Prior experience leading or supervising Quality Engineers or Supplier Auditors.
- Experience with supplier development, process capability improvement, or operational excellence projects.
- Experience working with global suppliers, including Asia and EU regions.
- Familiarity with ERP/QMS systems such as SAP, Agile, Windchill, TrackWise, or similar platforms.
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.
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:
HF Heart Failure
LOCATION:
United States > Pleasanton : 5000 Franklin Dr
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 50 % 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)
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