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.

Senior Specialist Quality Assurance

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and 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.Free medical coverage for employees* via the Health Investment Plan (HIP) PPOAn excellent retirement savings plan with high employer contributionTuition 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Alameda, CA location in the Diabetes Care division where 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.

As the Senior Specialist Quality Assurance you will be responsible for interpreting applicable internal and external requirements and translate to produce documents such as procedures and partnership agreements that are inline with the Quality System. Define process improvements to ensure consistent implementation of internal requirements and external laws, regulations, guidance and standards.

What You’ll Work On

Identifies internal requirements and external laws, regulations, guidance and standards (LRGS) applicable to one or more of division's quality systems Interprets applicable internal requirements and external LRGS and incorporate into requirements for use in business processes internally or with external partners. Identifies areas of potential noncompliance within Abbott or with external partners. Assist in the development, review, approval, and change control of  Quality System and/or external partnership related documents. Participates cross functionally and across business units to standardize Abbott business quality system policies and procedures. Ensures internal activities and external partnership activities meet applicable regulations and quality standards including FDA QSR and ISO 9001/ ISO 13485 Ensures external partnership activities meet applicable regulations and quality standards including FDA QSR and ISO 9001/ ISO 13485. Assists in the evaluation, development, and maintenance of Quality Agreements. Initiates and maintains design and on-market change notifications between the division and External Partners. Leads and implements process improvement initiatives. Collects and analyzes quality data as needed for monthly metrics and data driven recommendations based on trends. Provides support in external inspections/audits. Performs other duties as assigned by Management.

Required Qualifications

Bachelors Degree or an equivalent combination of education and work experienceMinimum of 5 years of experience in Quality Assurance or a related fieldMinimum 3 years of Medical Device industry experienceSome working Knowledge of applicable regulations and standards such as, FDA QSR and ISO 13485

Preferred Qualifications

Medical Device experience preferredAbility to manage multiple tasks and priorities. Strong Microsoft Office capabilities Experience with automated database systems. Ability to query and refine data into summarized results.Experience with cloud-based content management platformsAbility to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail. Ability to travel including internationally.

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.

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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 $86,700.00 – $173,300.00. In specific locations, the pay range may vary from the range posted.