Lead Quality Engineer: CAPA & Post-Market Expert

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

Benefits offered by this job

HIP PPO medical plan

Employer retirement contribution

Tuition reimbursement

FreeU education benefits

Job summary

Abbott in Alameda, CA is seeking a Lead Quality Engineer to own investigations related to product complaints and CAPA-driven actions. You will work cross-functionally to uncover root causes and ensure timely corrective actions in a healthcare environment.

This role requires deep technical product knowledge, strong problem-solving, and the ability to lead a team within the Post-Market Surveillance group across multiple Abbott business units.

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.

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.

Skills

Quality Assurance

CAPA investigations

Cross-functional collaboration

Problem solving

Education

Bachelor’s degree or higher

Job description

Abbott in Alameda, CA is seeking a Lead Quality Engineer to own investigations related to product complaints and CAPA-driven actions. You will work cross-functionally to uncover root causes and ensure timely corrective actions in a healthcare environment.

This role requires deep technical product knowledge, strong problem-solving, and the ability to lead a team within the Post-Market Surveillance group across multiple Abbott business units.