Senior Quality Engineer

Abbott; Pomona (CA); On-site; USD 90,000 - 180,000; Full time

Job summary

Abbott in Pomona, CA, is seeking a Senior Supplier Quality Engineer to lead quality engineering activities addressing product and process changes, regulatory compliance, and continuous improvement initiatives. This role partners with Operations to drive audits, CTQ measurement, and lifecycle management for IVD medical devices.

The position focuses on risk management, CAPA, and cross-functional collaboration with R&D, Manufacturing, and Design Engineering to ensure high-quality outcomes and

Qualifications

• Bachelor's degree in science or engineering.
• 5+ years experience in a quality role within biotechnology with 3-5 years progressive responsibility.
• Direct experience in IVD or medical device/regulated manufacturing environment preferred.
• ASQ CQE or other certifications preferred.
• Lean Six Sigma (Black or Green Belt) or Certified Quality Engineer/Auditor desired.

Responsibilities

• Drive continuous process improvement with Operations to conduct audits and implement enhancements.
• Develop, implement, and monitor process control systems and CTQ measures to ensure regulatory and customer requirements are met.
• Provide QA support for IVD medical device development and lifecycle management, including design controls and risk management.
• Lead risk management activities, including risk assessments, FMEA, and mitigation strategies.
• Investigate, resolve, and prevent nonconformances via CAPA and root-cause analysis.
• Design, execute, and document process optimization studies and reports for quality improvements.
• Collaborate cross-functionally with R&D, Manufacturing, Quality Control, Applications Support, and Design Engineering.
• Champion Lean Manufacturing and Six Sigma initiatives to improve processes and product performance.
• Manage multiple projects while providing leadership and mentorship to the team.

Skills

Quality engineering

Process improvement

Regulatory compliance

CAPA

Root cause analysis

Risk management

Education

Bachelor's degree in science or engineering

Job description

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 122,000 colleagues serve people in more than 160 countries.

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:

The Opportunity
This position works out of our Pomona, CA location in the CMI Business Unit, Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.

The Senior Supplier Quality Engineer will be responsible for quality engineering activities that address product/process changes, product/process quality issues, and compliance issues. This person will partner with operations for process improvement and continuous improvement initiatives and perform process audits of the operations areas. This person may be involved in the development of new products and as such would support design control activities.

What You’ll Work On

• Drive continuous process improvement by partnering with Operations to conduct process audits, identify opportunities, and implement sustainable enhancements that improve quality, efficiency, and compliance.
• Lead the development, implementation, and monitoring of process control systems and Critical-to-Quality (CTQ) measures to ensure products consistently meet internal, customer, and regulatory requirements.
• Provide Quality Assurance support for IVD medical device development and lifecycle management, ensuring compliance with design controls, risk management, quality planning, verification, validation, and change control processes.
• Lead risk management activities, including risk assessments, FMEA, and failure mode analysis, to identify potential issues and implement effective mitigation strategies.
• Investigate, resolve, and prevent product and process nonconformances through structured problem-solving, root cause analysis, CAPA, and quality improvement methodologies
• Design, execute, and document process optimization studies, experiments, protocols, and reports to support continuous improvement and product quality.
• Collaborate cross-functionally with R&D, Manufacturing, Quality Control, Applications Support, and Design Engineering teams to proactively address quality challenges and drive effective solutions.
• Champion Lean Manufacturing, Six Sigma, and other operational excellence initiatives to improve product performance, manufacturing processes, and overall business effectiveness.
• Manage multiple projects and priorities while providing leadership, coaching, and mentorship to support team development and successful project execution.
• Ensure compliance with Quality Management Systems (QMS), ISO, FDA, EMS, and company policies by supporting audits, regulatory requirements, documentation, validation activities, and continuous quality system improvement.

Required Qualifications

• Bachelors in fields of science such as Chemistry, Microbiology, Biology, Biochemistry, or Engineering.
• Minimum 5 years experience in a quality role within the biotechnology industry with 3-5 years of progressive responsible positions.

Preferred Qualifications

• Direct work experience in IVD or medical device/biotech or regulated manufacturing environment.
• ASQ CQE or other certifications preferred.
• Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
• Experience including new product development, design transfer, validation, QMS, and Supplier Audit experience is desired.Experience with reagent, ELISA, HEIA manufacturing desired.
• Lean Six Sigma (Black or Green Belt), Certified Quality Engineer, Certified Quality Auditor desired.
• Demonstrated supervisory experience preferred.
• Knowledge of IVDR in EU, FDA QSRs, ISO 13485:2016, ISO 14971:2012 standards and HACCP, GMP, GLP and GDP requirements.

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

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.

Get tailored jobrecommendations based on your interests.

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 122,000 colleagues serve people in more than 160 countries.

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 122,000 colleagues serve people in more than 160 countries.

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 122,000 colleagues serve people in more than 160 countries.

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At Abbott, sustainability means managing our efforts so we can help the greatest number of people around the world live fuller lives through better health.

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Abbott is an Equal Opportunity Employer. We are committed to providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local law. Employment decisions are based on qualifications, merit, and business needs.
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We provide reasonable workplace accommodations. U.S. residents only: To request accommodation, please call 224-667-0340or email [e-mail] .
Abbott is committed to pay equity and transparency. Compensation is determined using objective, job-related, gender-neutral criteria in compliance with applicable laws and local regulations.