Product Quality Engineering Manager: CAPA & Post-Market

Abbott; Alameda (CA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Career development

Free medical coverage (HIP PPO)

Retirement savings plan

Tuition reimbursement

FreeU education benefit

Job summary

Abbott in Alameda, CA is seeking a Manager, Product Quality Engineering to lead investigations of product complaints and drive post-market surveillance in the Diabetes Care division.

You will build and mentor a team, establish CAPA processes, and collaborate with Operations, R&D, QA, and Customer Service for timely corrective actions and strong quality systems.

This is a hands-on leadership role at a global healthcare leader delivering life-changing devices and technologies.

Qualifications

• Bachelors Degree required.
• At least 6 years of experience in quality engineering or related field.
• Quality Assurance in FDA/ISO regulated environment preferred.

Responsibilities

• Develop Product Quality Engineering teams to isolate root causes and recommend or implement effective solutions by means of sophisticated analysis, investigative techniques and troubleshooting methods.
• Establish effective team oversight of new product development to ensure post-market surveillance capabilities at time of launch.
• Responsible for establishing ADC investigation and reporting methodology as pertaining to elevated complaints and field issues identified.
• Work with the complaints group and CAPA team to analyze product issues and then conduct investigations to root cause and identify corrective actions to resolve.
• Collaborate with Operations, R&D, Quality Assurance, and Customer Service to determine cross-functional evaluation, investigation, and solutions.
• Represent Complaint Handling 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 and implements

Education

Bachelor's Degree

Job description

Abbott in Alameda, CA is seeking a Manager, Product Quality Engineering to lead investigations of product complaints and drive post-market surveillance in the Diabetes Care division.

You will build and mentor a team, establish CAPA processes, and collaborate with Operations, R&D, QA, and Customer Service for timely corrective actions and strong quality systems.

This is a hands-on leadership role at a global healthcare leader delivering life-changing devices and technologies.