Product Quality Engineering Manager

RXinsider LTD.; Alameda, Northern (CA, KY); Hybrid; USD 114,000 - 228,000; Full time

Benefits offered by this job

Health insurance (HIP PPO)

Retirement savings plan

Tuition reimbursement

FreeU education benefit

Job summary

Abbott is seeking a Manager, Product Quality Engineering in Alameda, CA. You will lead investigations on product complaints, drive post-market surveillance readiness, and guide CAPA activities. The role requires strong technical product knowledge and experience managing a quality team.

You will collaborate with Operations, R&D, QA, and Customer Service to ensure timely investigations and effective corrective actions across multiple Abbott business units.

Qualifications

• Bachelors Degree or higher in a related field.
• 6 years of overall experience and in industry-specific roles.
• Experience in FDA/ISO regulated environments is preferred.

Responsibilities

• Develop Product Quality Engineering teams to isolate root causes and implement solutions.
• Oversee post-market surveillance capabilities at time of launch.
• Establish ADC investigation and reporting methodology for elevated complaints.
• Collaborate with CAPA, Quality Assurance, Operations and R&D to resolve issues.
• Represent Quality Engineering in escalations and cross-functional reviews.
• Review and approve project and quality system documentation.

Skills

Leadership experience

Quality investigations

CAPA process

Cross-functional collaboration

Education

Bachelor's Degree

Job description

Abbott is seeking a Manager, Product Quality Engineering in Alameda, CA. You will lead investigations on product complaints, drive post-market surveillance readiness, and guide CAPA activities. The role requires strong technical product knowledge and experience managing a quality team.

You will collaborate with Operations, R&D, QA, and Customer Service to ensure timely investigations and effective corrective actions across multiple Abbott business units.