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 103,000 colleagues serve people in more than 160 countries.
This position is responsible for various data analysis activities including: complaints trending, MDR/MDV trending, and providing data reporting inputs for Management Review, various daily reporting and month-end activities.
- 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.
- Daily, weekly, monthly and quarterly product complaints reporting.
- Support internal and external audits by preparing and providing relevant reports/analysis, when applicable.
- Lead and/or participate in Corrective and Preventive Action (CAPA) Investigations, including documentation, implementation of actions and provision of status updates to management, electronically and in meetings.
- 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.
- Bachelor's degree or equivalent industry experience required.
- 3+ years experience in a manufacturing environment. Medical Device experience preferred.
- Ability to manage multiple tasks and priorities
- Strong Microsoft Office capabilities required, advanced ability with MS Excel preferred
- Experience with automated database systems. Knowledge and experience with 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 approximately 5%, including internationally.
JOB FAMILY:Operations Quality
LOCATION:United States > Minnesota > Plymouth : 5050 Nathan Lane N
TRAVEL:Yes, 5 % of the Time
MEDICAL SURVEILLANCE:Not Applicable
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
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