Lead Quality Engineer, CAPA & Post-Market

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

Benefits offered by this job

Health insurance

Tuition reimbursement

Retirement plan

Job summary

Abbott in Alameda, CA seeks a Lead Quality Engineer to own complex investigations in the CAPA system within Diabetes Care. You will drive root-cause analysis, establish ADC investigation methods, and work cross-functionally with Operations, R&D, QA, and Customer Service to implement effective conclusions.

The role emphasizes leadership, documentation excellence, and ongoing process improvements within Post-Market Surveillance, contributing to safer, higher-quality medical devices.

Qualifications

• Bachelor’s degree or equivalent with 8+ years QA experience; 12 years considered.
• Strong problem-solving and critical-thinking, especially in CAPA.
• Experience cross-functionally in quality investigations within a QMS.
• Healthcare/FDA/ISO regulated environment preferred.

Responsibilities

• Isolate root causes and implement effective solutions using analytical and investigative techniques for product issues.
• Establish ADC investigation and reporting methodology for elevated complaints and field issues.
• 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 at cross-functional level.
• Review and approve project and quality system documentation.
• Develop team members and implement process improvements within Post-Market Surveillance.

Skills

CAPA investigations

Cross-functional collaboration

Root cause analysis

Quality Assurance

Investigative skills

Documentation review

Education

Bachelor’s degree in related field

Tools

CAPA system

QMS documentation

Job description

Abbott in Alameda, CA seeks a Lead Quality Engineer to own complex investigations in the CAPA system within Diabetes Care. You will drive root-cause analysis, establish ADC investigation methods, and work cross-functionally with Operations, R&D, QA, and Customer Service to implement effective conclusions.

The role emphasizes leadership, documentation excellence, and ongoing process improvements within Post-Market Surveillance, contributing to safer, higher-quality medical devices.