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Under the direction of the department manager, the Postmarket Surveillance Analyst I may perform two different functions within the complaint handling. One role would be that of complaint investigation management and includes all activities pertaining to product complaints for Legacy SJM. This includes, but is not limited to: receiving and investigating reports of worldwide complaints/events on a variety of products; entering information into the complaint database; independently determining and filing appropriate medical devices reports with various regulatory agencies; participating on cross-functional teams; and providing information on product complaints, including data extracted from the complaint database to various teams (e.g. Regulatory, Quality Engineering).
Another role of the Postmarket Surveillance Analyst I is that of performing evaluations of returned complaint products, coordinating product testing/analysis with other departments and external consultants, preparing technical reports of findings and customer letters, operating and maintaining the Product Surveillance Laboratory and equipment, and collecting and evaluating analysis data. The Product Surveillance Analyst will also be able to perform trending of complaint data in either role as requested by management, including preparation of trending charts utilizing the complaint database and other programs, in support of the department Data Analyst. Depending on the site location of the PS Analyst, they may perform both complaint investigations and product analysis.
Communicates verbally and in writing both internally and externally to SJM regarding information needed specific to new product complaints (e.g. physicians, hospital personnel, sales representatives, international offices), initiates and manages the complaint file
Investigates complaints/events in a timely manner
Maintains accurate entry of complaints in database
Independently assesses the complaint to determine if a medical device report needs to be filed with various global regulatory agencies (e.g., FDA, European Competent Authorities) and sends reports within required timeframes
Prepares customer letters with findings
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
Utilizes safe bio-hazard and chemical handling practices at all times
Duties associated with either role:
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
Supports complaint database upgrades and conversions by providing input and performing system testing
Ensures accurate department procedures and work instructions are maintained
Support inspections by regulatory agencies (e.g. FDA, TUV) as requested.
The Product Surveillance Analyst must be able to:
Collaborate independently with other team members and departments needing product complaint information
Be able to conduct investigations with customers or field staff with minimal direction, utilizing experience and knowledge of products and various types of product complaints
Be able to make sound decisions regarding medical device reporting to various global regulatory agencies, minimizing the need for input from department management
Use procedures, judgement and experience to determine appropriate testing of returned products with minimal guidance
Be able to ascertain when additional support may be needed from other teams based on product analysis findings (e.g. potential manufacturing-related issues)
Train others in Product Surveillance product complaint handling
Provide support to Legal Dept on product complaints
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.
Four-year degree, preferably in the healthcare or science fields; or 2-year degree and relevant experience supporting complaint handling investigations, medical device reporting, or product analysis. Degreed applicants without medical, scientific, or complaint handling experience may be considered if they possess the strengths suitable for this position.
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.
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 maintain regular and predictable attendance.
JOB FAMILY:Operations Quality
LOCATION:United States > Texas : 6600 Pinecrest
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.
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