Quality Systems Analyst II

Quality Systems Analyst II

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 of which you dream.
• 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 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.

We are seeking a Quality Systems Analyst II to work our Westford, MA location for our Abbott Vascular division. This is a fully onsite role.

Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.

This position is responsible for various data analysis activities including: nonconformance trending, quality metric trending, and providing data reporting inputs for Management Review and various reporting and month end activities.

• Internal liaison and expert for quality metric database development, maintenance, and sustainment activities.
• Partner with cross-functional Quality and Business Unit Teams to fulfill reporting requirements. Includes, but not limited to: nonconformance/Corrective Action and Preventative Action (CAPA) 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.

• Bachelors Degree in a related field OR an equivalent combination of education and work experience
• Minimum 3 years in a manufacturing environment. Medical Device experience preferred.
• Ability to manage multiple tasks and priorities.
• Strong Microsoft Office capabilities required.
• 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.

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