Senior Quality Engineer

Abbott•Pomona, CA

24d•Onsite

About The Position

This position is based in Abbott’s Pomona, California location, in the CMI Business Unit of the Diagnostics Division. The Senior Supplier Quality Engineer performs quality engineering activities addressing product and process changes, quality issues, and compliance matters. The role partners with Operations on process and continuous improvement initiatives and conducts operational process audits. It may also support new product development and design control activities. The position provides quality assurance support for in-vitro diagnostic (IVD) medical device development and lifecycle management. It leads process improvement, process controls and Critical-to-Quality measures, risk management, investigations and corrective actions, process optimization studies, and quality-system compliance. The role collaborates across technical and operational teams and provides leadership, coaching, and mentorship while managing multiple projects and priorities.

Requirements

Bachelor’s degree in a science field such as Chemistry, Microbiology, Biology, or Biochemistry, or in Engineering.
At least 5 years of experience in a quality role within the biotechnology industry.
3–5 years in progressively responsible positions.
Strong project management and leadership skills, including demonstrated ability to lead multi-departmental project teams and resolve quality-related issues effectively and promptly.

Nice To Haves

Direct work experience in IVD, medical device or biotechnology, or a regulated manufacturing environment.
ASQ CQE or other certifications.
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, 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 conduct process audits, identify improvement opportunities, and implement sustainable enhancements to quality, efficiency, and compliance.
Develop, implement, and monitor process control systems and Critical-to-Quality measures.
Provide Quality Assurance support for IVD medical device development and lifecycle management, including design controls, risk management, quality planning, verification, validation, and change control.
Lead 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.
Design, execute, and document process optimization studies, experiments, protocols, and reports.
Collaborate with R&D, Manufacturing, Quality Control, Applications Support, and Design Engineering teams to address quality challenges and develop solutions.
Promote Lean Manufacturing, Six Sigma, and other operational excellence initiatives.
Manage multiple projects and priorities, and provide leadership, coaching, and mentorship.
Support audits, regulatory requirements, documentation, validation activities, and continuous quality system improvement to ensure compliance with QMS, ISO, FDA, EMS, and company policies.