Senior Data Analyst, Post-market Surveillance - Molecular Dx
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 113,000 colleagues serve people in more than 160 countries.
Abbott Molecular has an opening in its Des Plaines, IL site for a Specialist -Data Analyst, Post-market Surveillance
WHAT YOU’LL DO:
Under the direction of department management, the Product/Post-market Surveillance (PS) Data Analyst is responsible for trending product complaints and medical device reports utilizing data that resides in the complaint handling database for all product lines of CATD. This will include detailed data reports (e.g. graphs, charts, tables) prepared for routine monthly and quarterly trending, senior management reviews, ad-hoc requests, and cross-functional requests as needed (e.g. Regulatory, Quality Engineering, R&D). The Sr. PS Data Analyst will establish and maintain complex reporting formulas and templates using reporting tools such as Excel and other CATD databases (e.g. sales data, Business Objects). They will also ensure complaint data integrity for reporting by participating in or leading activities related to divisional complaint coding, data conversions, and system upgrades. This person will represent CATD PS complaint activities through support and collaboration with members of the PS team and cross-functional groups, while adhering to divisional and company policies for data security.
• Prepare monthly, quarterly, semi-annual, or ad-hoc trending reports on CATD product complaints at all levels of detail (e.g. product level, country, user level)
• Manage multiple projects while maintaining timelines
• Be vigilant of unusual trends related to product complaints and communicate them to management
• Provide input on the optimal organization and structure of the complaint database, as requested.
• Support complaint database upgrades, enhancements, issues, conversions by managing communications with vendors and applying patches with IT personnel
• Coordinate testing of upgrades/conversions by ensuring validation activities meet required regulations (e.g. test scripts are updated, executed and retained appropriately)
• Provide input and support of complaint coding activities for accuracy in trending
• Ensure complaint database is maintained to enabling consistent and retrievable data
• Provide complaint database training on reporting to CATD employees, as appropriate
• Support internal and external inspections by preparing relevant reports
• Represent PS by collaborating with other team members, and departments needing product complaint information
• Provide guidance on various complaint trending methods/improvements to management
• Maintain appropriate confidentiality when performing trending and providing reports to other individuals or groups
• Monitor and report abnormal product trends to department management
• Participate on project teams related to divisional/enterprise complaint data, as requested
• 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.
Education/ Skills/ Experience:
Education Level: Bachelors Degree (± 16 years)
Major/Field of Study: Statistics or data management preferred OR an equivalent combination of education and work experience
Experience/Background: Minimum 5 years
- Relevant work experience supporting data analysis and trending, preferably in a medical device manufacturing environment.
- Required skills include extensive knowledge of MS Excel and associated reporting formulas, as well as various databases or programs used in the collection and extraction of data (e.g. Business Objects), and strong written and oral communication skills are required. Experience with MS SQL Server, EtQ, or SAP Enterprise Software, a plus.
- Candidate must be able to work well independently and collaboratively on teams in a very busy department while managing multiple ongoing requests, projects, and timelines. Detailed problem-solving and ability to maintain confidentiality of sensitive information a must. Recognize and report abnormal trends, analyze data collection processes and procedures, and recommend improvements. 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 up to 20%, including internationally.
At Abbott, you can have a good job that can grow into a great career. We offer:
- Training and career development, with on-boarding programs for new employees and tuition assistance
- Financial security through competitive compensation, incentives and retirement plans
- Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
- Paid time off
- 401(k) retirement savings with a generous company match
- The stability of a company with a record of strong financial performance and history of being actively involved in local communities
Learn more about our benefits that add real value to your life to help you live fully: [Register to View]
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.