Quality Assurance Analyst

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 115,000 colleagues serve people in more than 160 countries.
JOB DESCRIPTION:
About Abbott
At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That's why we're focused on helping people with diabetes manage their health more effectively and comfortably, with lifechanging 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.
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) PPO
• An excellent retirement savings plan with 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 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.
Opportunity
The Quality Assurance Analyst primary objective is to provide administrative and clerical support to the calibration program at Alameda ADC.
What You'll Work On

• Responsible of processing, reviewing and approving receipt forms required for managing equipment life cycle in Maximo - Calibration Management System.
• Maintains Maximo and provides training to equipment owners as needed.
• Reviews Calibration certificates against preapproved equipment requirements and releases calibrated equipment back to equipment owners.
• Initiates Out of Tolerance and Repeat Out of Tolerance work orders for equipment that failed calibration, forwards work orders to equipment owners to conduct impact assessment and collaborates with equipment owners by reviewing and approving forms/records.
• Schedules calibration activities for field service & notifies other calibration coordinators of pending calibrations.
• Coordination of Quality Control (QC) equipment to send for calibration to external vendor (no calibration performed by QC).
• Coordinate equipment transfers between ADC and Calibration Vendor.
• Maintaining the equipment files. Ensuring all files are filed in Maximo in order and secured. Tracks progress of calibration documentation, and makes sure that this system complies with all QSR requirements.
• Ensures the calibration documentation is complete and up to date per sit procedure i.e.
• Generates and presents quarterly metrics to equipment owners, lab supervisors, and managers to demonstrate that the equipment calibration program is suitable and effective.
• Performs walkthroughs periodically for verifying that lab equipment remains labeled, supports internal/external audits by providing records and information needed to address questions.

Required Qualifications

• Minimum High School Diploma. Associate degree in science or technology desired. Bachelor's Degree in Engineering, Life Science, or physical science is preferred. A minimum of 4 years' experience in medical device or regulated industry.
• Knowledge in calibration systems and processes is desirable.
• Familiarity with cGMP, FDA, and ISO requirements.
• Must be able to operate a standard personal computer, and proficient in the use of various software applications like Maximo, Calibration Management System, and MS software such as Outlook, Word, Excel, PowerPoint, Vision, Teams, etc.
• Good interpersonal, communication, and organizational skills. Demonstrated experience working with cross functional groups/teams. Demonstrated ability to manage activities in order to meet pre-determined deadlines.

Apply Now*
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
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
$65,200.00 - $130,400.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
ADC Diabetes Care
LOCATION:
United States > Alameda : 2601 Harbor Bay Parkway
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf