Section Manager, QA Engineering

Abbott • CA

86d • $112,000 - $224,000

About The Position

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.

Requirements

• Bachelor's Degree in Engineering or related field.
• Mechanical or Biomedical Engineering Degree preferred.
• MBA strongly desired.
• 7+ years 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 years of experience in functional management.

Nice To Haves

• Working knowledge of applicable regulations and standards such as FDA, QSR, ISO 13485, ISO 14197, MDD and IVDD.
• Demonstrated written, oral and interpersonal skills.
• Strong analytical skills, problem solving techniques and statistical application experience.
• Knowledge in Medical Device Development, Design Controls, V&V activities, manufacturing practices, statistical techniques.
• Experience with Class II and Class III devices.
• Sterility assurance and packaging validation experience.
• Lean Six Sigma training or certification preferred.

Responsibilities

• Supervise engineers and technicians in the QA Engineering section.
• Contribute as Technical Design QA representative on new product design and on-market development/change teams.
• Manage Design Control metrics and equipment calibration oversight.
• Directly supervise a team of Quality engineers and analysts.
• Guide the team in sustaining and design product updates.
• Build and maintain cross-functional relationships with internal departments.

Benefits

• Free medical coverage in the Health Investment Plan (HIP) PPO medical plan.
• Excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement and Freedom 2 Save student debt program.
• FreeU education benefit for obtaining a bachelor’s degree.
• Recognition as a great place to work in multiple countries.
• Diversity and inclusion initiatives.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees