Senior Quality Engineer

Thornton Tomasetti; 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, quality issues, and regulatory compliance within the Diagnostics Division.

You will partner with Operations to drive process improvement, implement CTQ metrics, support design controls, risk management, CAPA, and cross-functional teams to ensure products meet internal, customer, and regulatory requirements.

Qualifications

• Bachelor's 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.
• Direct work experience in IVD or medical device/biotech or regulated manufacturing environment preferred.
• ASQ CQE or other certifications preferred.

Responsibilities

• 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 CTQ measures to ensure products meet 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 mitigate risks.
• Investigate, resolve, and prevent product and process nonconformances through CAPA and structured problem-solving.

Skills

Quality Assurance

Process Improvement

FMEA

CAPA

Lean Manufacturing

Six Sigma

Project Management

Regulatory Compliance

Education

Bachelor's degree in Chemistry, Microbiology, Biology, Biochemistry, or Engineering

Job description

## Senior Quality EngineerCandidatar-se: United States - California - Pomona: Tempo Integral: Publicado hoje: 31164537Abbott 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.Descritivo de Cargo **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 Managem* ent 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. **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/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 abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers.**The base pay for this position is**$90,000.00 – $180,000.00In specific locations, the pay range may vary from the range posted.Família de CargoOperations QualityDivisãoTOX ARDx ToxicologyLocalidadeUnited States > Pomona : 829 Towne Center DriveLocalidades AdicionaisTurno de TrabalhoStandardViagemYes, 25 % of the TimeVigilância médicaNot ApplicableAtividades de trabalho significativasContinuous 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