Senior Specialist Quality Assurance

Alameda CA Abbott Laboratories

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. 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.

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 Quality Systems Analyst II you will be responsible for various data analysis activities including: complaints trending, MDR/MDV trending, and providing data reporting inputs for Management Review and various reporting and month end activities.

What You’ll Work On

  • Internal liaison and expert for Complaint Handling database development, maintenance, and sustainment activities.

  • Partner with cross-functional Quality and Business Unit Teams to fulfill reporting requirements. Includes, but not limited to: Complaints Trending and summaries; FDA Medical Device Reporting trending and summaries; EU Medical Device Vigilance reporting trending and summaries; and Weekly, monthly and quarterly product line complaints reporting.

  • Support internal and external audits by preparing and providing relevant reports and analysis.

  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

  • Performs other related duties and responsibilities, on occasion, as assigned.

Required Qualifications

  • Bachelors Degree or an equivalent combination of education and work experience

  • Minimum 5 years in a manufacturing environment

Preferred Qualifications

  • Medical Device experience preferred

  • Ability to manage multiple tasks and priorities.

  • Strong Microsoft Office capabilities

  • Experience with automated database systems.

  • Knowledge and experience with InfoMed and SAP Enterprise Software highly desirable.

  • Ability to query and refine data into summarized results.

  • Experience with Microsoft SQL Server, Reporting Services, Analysis Services, a plus.

  • Experience working in a broader enterprise/cross-division business unit model preferred.

  • Ability 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

* 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 $83,600.00 – $167,200.00. In specific locations, the pay range may vary from the range posted.

To apply for this job please visit itjobpro.com.