Abbott

Senior Supplier Quality Assurance Engineer

Abbott • $90K — $180K *
Alameda, CA 94501In-Person
Healthcare
5 - 7 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's degree in engineering, Life Sciences, Quality, or similar field.
  • Minimum 2 years in a regulated environment such as medical devices or pharmaceuticals.
  • At least 5 years of experience in Supplier Quality or relevant quality roles.
  • Working knowledge of ISO 13485 and FDA QSR regulations.
  • Experience in conducting supplier audits (remote and onsite).
  • Proficiency in root cause analysis and CAPA management.
  • Strong communication skills with cross-functional teams.

Responsibilities

  • Lead supplier quality assurance activities to ensure compliance with quality standards and regulations.
  • Manage supplier onboarding and requalification processes, including risk assessments and documentation.
  • Plan and execute supplier audits, identifying gaps and driving corrective actions.
  • Monitor supplier performance through dashboards and targeted improvement initiatives.
  • Collaborate with various departments to resolve supplier-related quality issues.
  • Evaluate supplier changes and ensure appropriate risk assessments are conducted.
  • Serve as the lead contact for critical supplier quality issues.

Benefits

  • Health and wellness benefits for employees and their families.
  • Opportunities for diverse career advancement within the company.
Full Job Description
JOB DESCRIPTION:

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.

This position will be located out of our Alameda, CA office.

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: 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.

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

About Abbott

Abbott Careers

Joining Abbott means becoming part of a globally diverse team dedicated to making a lasting impact on human health. As a leader in healthcare innovation, Abbott provides a dynamic workplace where careers flourish through growth, leadership, and diversity training.

Opportunities at Abbott

Explore a world of opportunities with our team. Whether you're seeking job opportunities in engineering, marketing, research, or healthcare, Abbott offers a variety of positions that allow professionals to grow their careers. Our commitment to diversity and innovation is evident in every aspect of our work, fostering an inclusive culture that values each team member's contribution.

Work You'll Do

At Abbott, every role contributes to our mission of helping people live fuller lives through better health. From groundbreaking research in medical devices to advancements in pharmaceuticals, our team is at the forefront of healthcare innovation. By joining Abbott, you are not just accepting a job; you are embarking on a path of professional and personal growth.

Internship Programs

Kickstart your career with an Abbott internship. Our programs provide invaluable industry experience and a chance to develop essential skills in a real-world setting. Interns at Abbott work on projects that matter, gaining the experience and knowledge necessary to succeed in their future careers.

Professional Development

Abbott is dedicated to the continuous professional development of its employees. With access to cutting-edge technology, leadership programs, and diversity training, our team members are equipped to lead and innovate within the healthcare industry. We support your career journey with robust training programs, mentorship, and opportunities for networking and professional growth.

Benefits and Culture

Our employees enjoy comprehensive benefits designed to support their life and well-being. From health insurance to retirement plans, we ensure our team has everything they need to thrive. Abbott's culture is built on a foundation of respect and integrity, united by a shared commitment to improving health outcomes.

Join Our Team

Discover the impact you can make with a career at Abbott. We are hiring individuals who are passionate, curious, and driven to lead. Search open positions that match your skills and interests on our Jobs page. Prepare your resume, sharpen your interview skills, and get ready to join a team that's at the cutting edge of healthcare solutions.

Stay Connected

Keep up to date with career tips, industry insights, and company news—all from the people who work here. Subscribe to our Careers Blog and personalize your subscription to receive job alerts and insider tips tailored to your preferences.

Explore Abbott

With a commitment to improving life through innovation, leadership, and diversity, Abbott is a place where you can fulfill your potential. See what exciting and rewarding opportunities await at Abbott by exploring our career opportunities today.

SEARCH ABBOTT JOBS

Join us in our mission to make the world a healthier place through innovation, leadership, and diversity. Your journey to a fulfilling career at Abbott starts here.
Learn more about Abbott
Size
113,000 employees
Market Cap
$189 billion
Industry
Healthcare
Net Income
$4.4 billion
Founded
1944
5 Year Trend
+15.6%
Revenue
$34.6 billion
NASDAQ
ABT
* Ladders Estimates

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