Senior Quality Engineer (Complaint Handling)

Abbott Laboratories · Foster City · $90,000–$180,000 (stated in the posting)

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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 Toxicology Business Unit, Rapid and Molecular 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 (Complaint Handling) will be responsible for quality engineering activities that address product/process changes, product/process quality issues and resolution, complaint handling, and compliance issues.  This person will partner with operations for process improvement and continuous improvement initiatives and will engage in complaint handling to address potential customer concerns.  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 improve processes and resolve issues.
• Support 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; this includes participation with non-conformance, CAPA, and complaints.
• Administer Enterprise software for complaint handling; lodge and investigate customer inquiries and complaints.  Adhere to regulatory compliance requirements for issue reporting to regulatory bodies
• 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.
• Support 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.  Administer resolution of non-conformances and CAPA in Enterprise applications in conjunction with key stakeholders.
• Collaborate cross-functionally with R&D, Manufacturing, Quality Control, Applications Support, and Design Engineering teams to proactively address quality challenges and drive effective solutions.
• 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.
• 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.

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 – $180,000.00. In specific locations, the pay range may vary from the range posted.

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