Senior Quality Engineer

Abbott Laboratories•Pomona, CA

22d•$90,000 - $180,000•Onsite

About The Position

The Senior Supplier Quality Engineer works in Abbott’s Toxicology Business Unit, Rapid and Molecular Diagnostics Division, at the Pomona, California location. The role is responsible for quality engineering activities addressing product and process changes, quality issues and resolutions, complaint handling, and compliance. The engineer partners with Operations on process and continuous improvement initiatives and handles complaints to address potential customer concerns. The role may also support new product development and design control activities. The position supports IVD medical device development and lifecycle management, including design controls, risk management, quality planning, verification, validation, and change control. It works cross-functionally with R&D, Manufacturing, Quality Control, Applications Support, and Design Engineering, and supports audits, regulatory requirements, documentation, validation, and ongoing quality system improvement. The role also involves managing multiple projects and providing leadership, coaching, and mentorship.

Requirements

Bachelor’s degree in a science field such as Chemistry, Microbiology, Biology, Biochemistry, or Engineering.
At least 5 years of experience in a quality role within the biotechnology industry.
3–5 years in progressively responsible positions.

Nice To Haves

Direct experience in IVD, medical device, biotechnology, or regulated manufacturing environments.
ASQ CQE or other certifications.
Strong project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues effectively and promptly.
Experience with new product development, design transfer, validation, QMS, and supplier audits.
Experience with reagent, ELISA, or HEIA manufacturing.
Lean Six Sigma Black Belt or Green Belt certification, Certified Quality Engineer, or Certified Quality Auditor credentials.
Demonstrated supervisory experience.
Knowledge of EU IVDR, FDA QSRs, ISO 13485:2016, ISO 14971:2012, and HACCP, GMP, GLP, and GDP requirements.

Responsibilities

Partner with Operations to improve processes and resolve issues through continuous process improvement.
Support development, implementation, and monitoring of process control systems and Critical-to-Quality (CTQ) measures.
Participate in non-conformance, CAPA, and complaint processes to help ensure products meet internal, customer, and regulatory requirements.
Administer enterprise complaint-handling software; lodge and investigate customer inquiries and complaints, and comply with regulatory reporting requirements.
Provide Quality Assurance support for IVD medical device development and lifecycle management, including design controls, risk management, quality planning, verification, validation, and change control.
Support risk management activities, including risk assessments, FMEA, and failure mode analysis, and implement mitigation strategies.
Investigate, resolve, and prevent product and process nonconformances using structured problem-solving, root cause analysis, CAPA, and quality improvement methodologies.
Administer non-conformance and CAPA resolutions in enterprise applications with key stakeholders.
Collaborate with R&D, Manufacturing, Quality Control, Applications Support, and Design Engineering to address quality challenges and implement solutions.
Manage multiple projects and priorities, and provide leadership, coaching, and mentorship to support team development and project execution.
Support audits, regulatory requirements, documentation, and validation activities; ensure compliance with QMS, ISO, FDA, EMS, and company policies; and contribute to continuous quality system improvement.