New · posted Oct 16
Abbott · Medical Devices
Senior Quality Engineer
- Pomona, CA
- On-site
- Full-time
- Senior & Principal
Open until filled
The role
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.
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.
What you need
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 Qualificationsnice to have
- 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.
What you'll do
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 Managem
- ent Systems (QMS), ISO, FDA, EMS, and company policies by supporting audits, regulatory requirements, documentation, validation activities, and continuous quality system improvement.
Pay and benefits
$90,000 – $180,000 a year
Employer providedThe base pay for this position is
$90,000.00 – $180,000.00
In specific locations, the pay range may vary from the range posted.
Health and wellness benefits
Where you'll work
Pomona, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in Pomona, CAWorking conditions
Standard
TRAVEL
Yes, 25 % of the Time
MEDICAL SURVEILLANCE
Not Applicable
Apply Now
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://abbottbenefits.com/
Connect with us at abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers.
JOB FAMILY
Operations Quality
DIVISION
TOX ARDx Toxicology
LOCATION
United States > Pomona : 829 Towne Center Drive
From the posting
About Abbott
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:
Equal opportunity, accessibility and legal noticesAbbott's statements, word for word
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.
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), Routine work with chemicalsAbbott 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.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
Job intelligence
The context around this role
Live data · October 16, 2026
Salary intelligence
How the pay compares
This role's midpoint is 10% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in California85 roles publishing pay
Senior & Principal roles in the US285 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $90,000 | — | $180,000 |
| California (middle half) | $117,500 | $135,000 | $158,500 |
| All US (middle half) | $104,000 | $122,500 | $137,500 |
This role: Abbott's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 16, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 866 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Abbott's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 23 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance8
- Quality systems and risk8
- Collaboration and leadership6
- Lab testing and methods4
- Validation and qualification3
- Documentation and SOPs2
- Investigations and CAPA1
- Regulatory submissions1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices
- FDA21 CFR Part 58 (GLP)(official source, opens in a new tab)Good laboratory practice for nonclinical laboratory studies
- European CommissionEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules and annexes
- European UnionEU IVDR (Regulation 2017/746)(official source, opens in a new tab)The EU In Vitro Diagnostic Medical Devices Regulation
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- ISOISO 14971(official source, opens in a new tab)Risk management for medical devices
Company hiring pulse
Abbott on Regulatory Jobs
- 81
- Open roles
- 75
- Distinct roles
- 32
- Locations
By discipline
- Quality54 67%
- Regulatory25 31%
- Compliance & Safety2 2%
By level
- Senior & Principal41 51%
- Associate & Specialist23 28%
- Manager14 17%
More roles at Abbott
- View role
Senior Engineer Quality Systems
Irving, TXSenior & PrincipalMedical Devices$78K–$156K
- View role
Quality Engineer
Caguas, PRAssociate & SpecialistMedical Devices$54K–$109K
- View role
Senior Quality Technician
Minnetonka, MNSenior & PrincipalMedical Devices$49K–$98K
- View role
Site Quality Leader
Plymouth, MNDirectorMedical Devices$149K–$299K
Similar Quality Assurance roles elsewhere
- View role
Senior Supplier Quality Engineer
iRhythmOrange County, CA · HybridSenior & PrincipalMedical Devices$99K–$129K
- View role
Senior Design Quality Engineer
iRhythmSan Francisco, CA +1 more · HybridSenior & PrincipalMedical Devices$138K–$180K
- View role
Sr. Supplier Quality Engineer I
Tandem Diabetes CareSan Diego, CA · HybridSenior & PrincipalMedical Devices$100K–$123K
- View role
Sr. Quality Engineer - Manufacturing
Tandem Diabetes CareCaliforniaSenior & PrincipalMedical Devices$110K–$121K
Senior Quality Engineer at Abbott
Open until filled. $90K–$180K a year, employer provided.