Senior Specialist Quality Assurance

Abbott • Alameda, CA • 22h ago

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.

Sr. Specialist Quality Assurance

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 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 (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program, and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) 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.

What You'll Work On

The Sr. Specialist Quality Assurance will be responsible for training, oversight and measuring performance of complaint investigators and receiving clerks who investigate product returned by ADC customers in the Complaints Investigation Lab. The Sr. Specialist Quality Assurance is expected to understand all aspects of the complaints investigations processes, manage resources to meet division goals for timeliness of complaint investigations and identify opportunities for improvement and/or better efficiencies in our investigation processes. The individual will also responsible for monitoring the quality of the complaints investigations that are performed.

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.

Main Responsibilities

The Sr. Specialist Quality Assurance leads complaint investigation activities with regard to blood glucose meters.

Ensures that complaints investigations are done according to procedures in a timely manner.

Monitors people and processes with an eye towards improving the efficiency of the investigations that are performed.

Responsible for identifying any trends in product complaints that are found during investigations.

Responsible for tracking all returned product, calibration and proper validation of all test equipment within the lab.

Assists Lab Supervisor in performance evaluations as well as administrative duties.

Responsible for compliance with applicable Corporate and Divisional Policies and performing other duties as assigned by management

Required Qualifications

Bachelors degree or equivalent experience is required.

Equivalent combination of education and mins of 5 yrs of work experience will be considered.

Previous experience with complaints investigations in a regulated environment and knowledge of the FDA/QSR regulation and ISO 13485 standard is required.

An understanding of ADC product is ideal. Must be able to effectively lead a large staff of non-exempt employees including full-time and contract workers.

Excellent communications skills are required as there may be interaction with other functions in ADC such as Customer Support, R&D, and Manufacturing.

Must also be able to act autonomously and make decisions regarding the need to pursue further investigation vs. bring closure to an investigation.

Complaints investigations are a primary focus of corporate and FDA audits.

Investigations that are not conducted or documented properly could lead to an observation for ADC.

Preferred Qualifications

Preferred experience in the Healthcare industry.

Has a history of completing successful projects and driving positive compliance outcomes.

Apply Now (https://www.jobs.abbott/us/en)

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx)

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 ?ngersticks.

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.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com

Abbott

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