Senior Quality Engineer; Complaint Handling

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…