Lead Quality Engineer – CAPA & Post‑Market Leadership

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

Job summary

Abbott Laboratories is seeking a Lead Quality Engineer to own complex investigations linked to product complaints in the Diabetes Care division at Alameda, CA. You will drive root-cause analyses, establish ADC investigation methods, and coordinate cross-functional actions with Operations, R&D, QA, and Customer Service to ensure timely corrective actions.

Ideal candidates have strong CAPA experience and a track record in FDA/ISO-regulated environments.

Qualifications

• Bachelor's degree with a minimum of 8 years of experience in Quality Assurance or a related field.
• Equivalent combination of education and experience may count 12 years.
• Demonstrated initiative and problem-solving 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 using advanced analysis.
• Establish ADC investigation and reporting methodology for elevated complaints.
• Collaborate with Operations, R&D, QA, and Customer Service for cross-functional evaluation.
• Represent Post-Market Surveillance and Product Quality Engineering in escalations and urgent issues.
• Review and provide functional approval for project and quality system documentation.
• Develop team members and implement process improvements within Post-Market Surveillance.

Skills

Cross-functional collaboration

CAPA investigations

Root cause analysis

Investigative QA work

Education

Bachelor's degree in QA or related field

Job description

Abbott Laboratories is seeking a Lead Quality Engineer to own complex investigations linked to product complaints in the Diabetes Care division at Alameda, CA. You will drive root-cause analyses, establish ADC investigation methods, and coordinate cross-functional actions with Operations, R&D, QA, and Customer Service to ensure timely corrective actions.

Ideal candidates have strong CAPA experience and a track record in FDA/ISO-regulated environments.