Senior Quality Engineer - CAPA & Post-Market Leader

Thornton Tomasetti; Alameda (CA); On-site; USD 100,000 - 200,000; Full time

Job summary

Abbott Alameda is seeking a Lead Quality Engineer to own investigations of complex product complaints and CAPA‑driven actions in the Diabetes Care division. You will work to identify root causes and drive effective corrective actions across teams.

The role requires a strong technical understanding of the product and investigation methods, with cross‑functional collaboration with Operations, R&D, QA, and Customer Service to ensure timely resolutions.

Qualifications

• Bachelor’s degree with a minimum of 8 years of experience in Quality Assurance or a related field required.
• An equivalent combination of education and experience, including a minimum of 12 years of relevant experience, will also be considered.
• Demonstrated initiative and problem‑solving skills; critical‑thinking skills, preferably in a CAPA environment.
• Experience working cross‑functionally in an investigative role in a Quality management system.
• Quality Assurance and healthcare industry disciplines preferred.
• Minimum 4 years overall quality experience in an FDA/ISO regulated environment preferred.

Responsibilities

• Isolate root causes and implement effective solutions by means of sophisticated analysis and investigative techniques for product issues.
• Responsible for establishing ADC investigation and reporting methodology as pertaining to elevated complaints and field issues identified.
• Collaborate with Operations, R&D, Quality Assurance, and Customer Service to determine cross‑functional evaluation, investigation, and solutions.
• Represent Post‑Market Surveillance and Product Quality Engineering in escalations and urgent issues being addressed at a cross‑functional or divisional level.
• Reviews and provides functional approval for project and quality system documentation.
• Develops members of the team and implements process improvements within the Post‑Market Surveillance team.

Education

Bachelor’s degree

Job description

Abbott Alameda is seeking a Lead Quality Engineer to own investigations of complex product complaints and CAPA‑driven actions in the Diabetes Care division. You will work to identify root causes and drive effective corrective actions across teams.

The role requires a strong technical understanding of the product and investigation methods, with cross‑functional collaboration with Operations, R&D, QA, and Customer Service to ensure timely resolutions.