Senior Quality Engineer (Complaint Handling)

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

Job summary

Abbott, a global healthcare leader, seeks a Senior Supplier Quality Engineer (Complaint Handling) at the Pomona, CA site. You will drive complaint handling, CAPA, and risk management with cross-functional teams to ensure product quality and regulatory compliance.

In this role, you’ll collaborate with R&D, Manufacturing, and QA to address nonconformances, lead process improvements, and support audits under QMS, FDA, and ISO standards. A strong quality background in biotech is essential.

Qualifications

• Bachelor’s degree in science or engineering and at least 5 years in biotech quality.
• 3–5 years of progressive responsibility in quality roles.

Responsibilities

• Drive continuous process improvement with Operations to enhance processes and resolve issues.
• Develop and monitor process control systems and CTQ measures to meet requirements.
• Administer complaint handling; investigate inquiries and adhere to regulatory reporting.
• Provide QA support for IVD medical device development and lifecycle management.
• Support risk management activities including FMEA and risk assessments.
• Investigate and resolve nonconformances using CAPA and root cause analysis.
• Collaborate with R&D, Manufacturing, QC, Applications Support and Design Engineering.
• Lead multiple projects, providing mentorship and cross-functional leadership.
• Ensure compliance with QMS, ISO, FDA, and GMP standards; support audits and validation.

Skills

Quality engineering

Process improvement

CAPA

Regulatory compliance

Root cause analysis

Leadership

Cross-functional leadership

Project management

Education

Bachelor's degree in science/engineering

Tools

QMS software

CAPA systems

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.

JOB DESCRIPTION:

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.

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 abott.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.

JOB FAMILY:

Operations Quality

DIVISION:

TOX ARDx Toxicology

LOCATION:

United States > Pomona : 829 Towne Center Drive

WORK SHIFT:

Standard

TRAVEL:

Yes, 25 % of the Time

MEDICAL SURVEILLANCE:

Not Applicable

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), Routine work with chemicals

Abbott 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.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf