Analyst I, Product Surveillance (31026369)
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 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 109,000 colleagues serve people in more than 160 countries.JOB DESCRIPTION:
This position is responsible for performing investigations on complaint product to determine root cause as it relates to the alleged issue. Analysts may coordinate with other cross-functional engineering partners within the business to complete accurate, consistent, and timely investigation reports.
WHAT YOU’LL DO
Investigates complaints/events in a timely manner.
Maintains accurate entry of complaints in database.
Records condition of returned products including observations, photographs. Coordinates product testing/analysis with other departments and external consultants
Prepares technical reports of analysis/findings--Tracks returned products within the database, as appropriate
Works collaboratively with cross-functional groups (e.g. QEs, R&D) on evaluation trends or findings
Interprets technical product specifications, Device History Records, or measurements obtained
Understand and apply risk analysis; and Utilizes safe bio-hazard and chemical handling practices at all times
Is diligent of any unusual trends in product complaints
Participates in cross-functional complaint review groups on a regular basis or as requested (e.g. cross-functional complaint teams, rapid customer response team, Risk Management meetings)
Archives complaint records or returned products & retrieves information on previous investigations; and support inspections by regulatory agencies as requested
Must be able to: Collaborate independently with other team members and departments needing product complaint information; Be able to conduct investigations with minimal direction, utilizing experience and knowledge of products and various types of product complaints; Use procedures, judgment and experience to determine appropriate testing of returned products with minimal guidance.
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.
Work environment varies from well lighted office/cubicle, low to moderate noise level, to a variety of conditions caused by travel requirements such as customer offices, research labs, hospitals, hotels, use of automobiles, commercial travel, weather, etc.
Activities require a significant amount of sitting in front of a computer monitor, some standing and walking.
Significant use of hands and arms, plus finger dexterity to reach, point, write, type, operate a computer and other office equipment.
Performs tasks that regularly require good correctable vision and hand/eye coordination. Activities also require significant use of voice and hearing for discussions with other employees.
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.
Multitasks, prioritizes and meets deadlines in timely manner.
Strong organizational and follow-up skills, as well as attention to detail.
Knowledge of global regulations for medical device reporting and medical terminology is a plus.
Strong written and oral communication skills are required.
Candidate must be able to work well independently and on teams in a busy department while managing multiple ongoing tasks and investigations simultaneously.
Good problem-solving and proficient computer skills are required.
- Bachelors Degree (± 16 years)
- Preferably in the biological science or engineering fields. Degreed applicants without medical, scientific, or complaint handling experience may be considered if they possess the strengths suitable for this position.
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
Training and career development, with onboarding 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] , on Facebook at [Register to View] target="_blank">[Register to View] and on Twitter @AbbottNews and @AbbottGlobal
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
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EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf