Section Manager, QA Engineering

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

Job Description:

Section Manager, QA Engineering

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

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

• 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 – 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

• Working knowledge 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 the areas of Medical Device and Development, Design Controls, V&V activities, mfg practices, statistical techniques.
• Experience with Class II and Class III devices.
• Sterility assurance and packaging validation experience a plus.
• Knowledge of medical product quality assurance (incl the requirement for test protocols and statistical techniques).
• Individual must be able to understand the business side of the project deliverables to ensure a realistic quality/project strategy.
• Lean Six Sigma training or certification preferred.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

Base Pay: $112,000.00 – $224,000.00

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

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