Quality Systems Analyst II
About The Position
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. 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.
Requirements
- Bachelors Degree in a related field OR an equivalent combination of education and work experience
- Minimum 3 years in a manufacturing environment.
- Ability to manage multiple tasks and priorities.
- Strong Microsoft Office capabilities required.
- Experience with automated database systems.
- Ability to query and refine data into summarized results.
- 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.
Nice To Haves
- Medical Device experience preferred.
- Knowledge and experience with InfoMed and SAP Enterprise Software highly desirable.
- Experience with Microsoft SQL Server, Reporting Services, Analysis Services, a plus.
- Experience working in a broader enterprise/cross-division business unit model preferred.
Responsibilities
- 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.
- Prepare and provide relevant reports and analysis to support internal and external audits.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
- Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Perform other related duties and responsibilities, on occasion, as assigned.
Benefits
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
