Lead Quality Engineer – Post-Market CAPA & Investigations

Abbott; United States; On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

HIP medical plan

Retirement plan

Tuition reimbursement

FreeU education

Job summary

Abbott is seeking a Lead Quality Engineer based in Alameda, CA in the Diabetes Care division to own complex investigations of product complaints and CAPA processes, ensuring timely root-cause analysis and effective corrective actions.

You will partner with Operations, R&D, Quality Assurance and Customer Service to drive cross-functional solutions, review documentation, and develop team capabilities within Post-Market Surveillance.

Qualifications

• Bachelor's degree in a related field with strong QA foundation.
• Minimum 8 years of experience in Quality Assurance or a related field.
• Equivalent combination of education and experience considered with 12 years experience.
• Demonstrated initiative, problem-solving, and critical thinking in CAPA environments.
• Experience working cross-functionally in a Quality Management System.

Responsibilities

• Own complex investigations for product complaints and CAPA within the CAPA system.
• Isolate root causes and implement corrective actions for trends and issues.
• Collaborate with Operations, R&D, Quality Assurance, and Customer Service to drive solutions.
• Represent Post-Market Surveillance and Product Quality Engineering in escalations.
• Review and approve project and quality system documentation.
• Mentor team members and drive process improvements within the Post-Market Surveillance group.

Skills

Quality Assurance

CAPA investigations

Root cause analysis

Cross-functional collaboration

Investigations in QA systems

Education

Bachelor's degree in a related field

Job description

Abbott is seeking a Lead Quality Engineer based in Alameda, CA in the Diabetes Care division to own complex investigations of product complaints and CAPA processes, ensuring timely root-cause analysis and effective corrective actions.

You will partner with Operations, R&D, Quality Assurance and Customer Service to drive cross-functional solutions, review documentation, and develop team capabilities within Post-Market Surveillance.