Senior Specialist Quality Assurance

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.**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. Youll 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) PPO+ An excellent retirement savings plan with 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 bachelors 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. Were revolutionizing the way people monitor their glucose levels with our new sensing technology.The Sr. SQA 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. You will be 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. You will also be responsible for monitoring the quality of the complaints investigations that are performed.**What Youll Work On**+ 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. Also 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 experience is defined as a minimum of 2 - 4 years work experience.+ 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 (Abbott Diabetes Care) 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.Apply Now (https://www.jobs.abbott/us/en)* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.**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 and @AbbottGlobal.The base pay for this position is $83,600.00 $167,200.00. In specific locations, the pay range may vary from the range posted.An Equal Opportunity EmployerAbbot 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