Senior Quality Engineer

Biopharma Careers; Pomona (CA); On-site; USD 100,000 - 140,000; 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, complaints, and regulatory compliance. The role partners with operations for continuous improvement, supports design controls and lifecycle management for IVD devices, and drives CAPA effectiveness to ensure patient safety and product quality.

The position requires strong problem-solving, risk management, and cross-functional collaboration across R&D,

Qualifications

• Quality engineering activities addressing product/process changes and complaints.
• Engage in non-conformance, CAPA, and complaints processes.
• Support design controls, risk management, and lifecycle management for IVD devices.

Responsibilities

• Drive continuous process improvement with Operations to resolve issues.
• Develop, implement, and monitor CTQ measures to meet requirements.
• Administer enterprise software for complaint handling and investigations.
• Collaborate with R&D, Manufacturing, QC, Applications Support, and Design Engineering to address quality challenges.
• Lead multiple projects with coaching and mentorship to the team.

Skills

Process Improvement

CAPA

Root Cause Analysis

Risk Management

Quality Assurance

Cross-functional Collaboration

Regulatory Compliance

Tools

Enterprise Software

Job description

# Senior Quality EngineerPomona, California, United States FULL\\_TIMENotify me about similar jobsView Full Job & Apply at AbbottAbbott is the source of truth for this posting and owns the application process. We surface normalized context and market comparison you won't find on the original listing.## About this opportunityAbbott 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** 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 bodiesProvide 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.