Senior Manager, Product Quality Engineering

Abbott (abbottcareers2 board); United States; On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Free medical coverage

Retirement plan

Tuition reimbursement

Education benefit

Diversity recognition

Job summary

Abbott in Alameda, CA, is seeking a Manager, Product Quality Engineering to lead a team responsible for investigations of product complaints and CAPA activities in the Diabetes Care division. The role focuses on post-market surveillance and ensuring new products are launch-ready from a quality perspective.

You will develop and oversee QA investigations, partner with Operations, R&D, QA and Customer Service, and drive corrective actions when needed.

Qualifications

• Bachelor's degree in a related field.
• 6 years of experience overall and in healthcare/regulated environments.

Responsibilities

• Develop Product Quality Engineering teams to isolate root causes and implement effective solutions using analysis and investigations.
• Establish team oversight of new product development to ensure post-market surveillance at launch.
• Establish ADC investigation and reporting methodologies for elevated complaints and field issues.
• Collaborate with complaints group and CAPA team to analyze product issues and conduct root-cause investigations to identify corrective actions.
• Work with Operations, R&D, QA, and Customer Service for cross-functional evaluation and solutions.
• Represent Complaint Handling and Product Quality Engineering in escalations at cross-functional or divisional levels.
• Review and approve project and quality system documentation.
• Develops and implements improvements.

Skills

Root cause analysis

CAPA investigations

Team leadership

Quality systems

Education

Bachelor's degree

Tools

CAPA system

Job description

Abbott in Alameda, CA, is seeking a Manager, Product Quality Engineering to lead a team responsible for investigations of product complaints and CAPA activities in the Diabetes Care division. The role focuses on post-market surveillance and ensuring new products are launch-ready from a quality perspective.

You will develop and oversee QA investigations, partner with Operations, R&D, QA and Customer Service, and drive corrective actions when needed.