Section Manager, QA Engineering

The Opportunity

The Section Manager, QA Engineering will both supervise engineers and technicians as well as contribute individually as Technical Design QA representative on new product design and on-market development / change teams. The Section Manager will have expertise in medical device Design Controls as well as work with RA on emerging regulations and assess impact to the designs. They will build and maintain successful cross functional relationships with internal departments such as R&D Engineering, Operations, Quality and Regulatory Affairs. Provide support, as needed, to Clinical Material Release, Quality Control, and Calibration programs.

This position will be based out of our Abbott Diabetes Care in Alameda, CA and the individual will be expected to be onsite Monday-Friday.

What You’ll Work On

The Section Manager will work on new product introduction medical device programs as well as guide the team in sustaining and design product updates. They will manage Design Control metrics, equipment calibration oversight, and directly supervise a team of Quality engineers and analysts.

Required Qualifications

• Bachelors Degree in Engineering or related field. Mechanical or Biomedical Engineering Degree preferred. MBA strongly desired.
• 7+ yrs of experience in Quality Assurance or Engineering.
• Minimum 5 years of experience in the Medical Device Manufacturing or Pharma industry.
• Minimum 3 years direct experience in Design Control
• Minimum 5 yrs of experience in functional management – experience managing direct reports.
• Must be able to lead new product development teams in addressing the technical quality issues arising for complex new diabetes care related products.

Preferred Qualifications