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Abbott · 17 hours ago

Postmarket Surveillance Analyst I

Plymouth, MN

Full-time

Onsite

Entry Level

$50K/yr - $100K/yr

2+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. The Postmarket Surveillance Analyst I will perform evaluations on returned complaint products, coordinating testing and analysis, preparing technical reports, and maintaining laboratory equipment to ensure compliance with regulatory guidelines.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

Performs product evaluations in a timely manner to develop a well-documented and accurate root cause evaluation

Uses procedures, judgement and experience to determine appropriate testing of returned products with minimal guidance

Reviews all pertinent information to complete the evaluation (e.g. photos, study or log files, field service reports, external investigations)

Ascertain when additional support may be needed from other teams based on product evaluation findings (e.g. potential manufacturing-related issues) and coordinate product evaluations with other Abbott departments and external consultants when needed

Interprets/reviews technical product specifications, measurements, and the Device History Record

Prepares technical reports of findings and enters them into the complaint system; maintains accurate entry of complaints in the database

Maintains work area in clean and orderly condition and adheres to safety and biohazard procedures

Independently assesses the evaluation results to determine if they meet regulatory reporting guidelines and inform the appropriate Postmarket Surveillance team member of the findings

Adheres to the device retention and disposal procedures

Is diligent of any unusual trends in product complaints and communicates them to management

Participates in cross-functional complaint review groups on a regular basis or as requested (e.g. cross-functional complaint teams, new product teams, risk management meetings)

Ensures accurate department procedures and work instructions are maintained

Train new employees to the complaint handling process

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

Qualification

Medical device reportingProduct evaluationComplaint handlingRegulatory complianceTechnical report preparationCommunication skillsProblem-solvingOrganizational skillsTeam collaboration

Required

Four-year degree, preferably in the healthcare, science, or technical fields; or 2-year degree and 10 years of relevant experience supporting complaint handling investigations, medical device reporting, product evaluation, or related work

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

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 10%, including internationally

Ability to maintain regular and predictable attendance