Abbott Laboratories
Section Manager, QA Engineering
Abbott Laboratories, Alameda, California, United States, 94501
Overview
Section Manager, QA Engineering Working at Abbott 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 forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical 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
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
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. Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:
www.abbottbenefits.com Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at
www.abbott.com , on Facebook at
www.facebook.com/Abbott , and on Twitter @AbbottNews. Divisional Information
Medical Devices General Medical Devices: Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks. Diabetes We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. The base pay for this position is $112,000.00 – $224,000.00. In specific locations, the pay range may vary from the range posted.
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Section Manager, QA Engineering Working at Abbott 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 forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical 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
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
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. Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:
www.abbottbenefits.com Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at
www.abbott.com , on Facebook at
www.facebook.com/Abbott , and on Twitter @AbbottNews. Divisional Information
Medical Devices General Medical Devices: Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks. Diabetes We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. The base pay for this position is $112,000.00 – $224,000.00. In specific locations, the pay range may vary from the range posted.
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