Analyst - Product Surveillance
5050 Nathan Lane N Plymouth, MN 55442
Voca has an immediate opening available for a Analyst - Product Surveillance in Plymouth, Minnesota!
- We are seeking an experienced, high caliber Analyst II, Postmarket Surveillance. The Postmarket Surveillance Analyst performs evaluations on various types of returned devices associated with reported complaints. Analysis involves using procedures, judgement and experience to determine appropriate testing of returned products; determining a well-documented and accurate root cause evaluation; reviewing of Device History Records; coordinating product testing/analysis with other Abbott departments and external consultants; and preparing technical reports of evaluations. Other tasks include operating and maintaining the Postmarket Surveillance laboratory equipment, interpreting technical product specifications, maintaining clean and orderly work area, adhering to safety and biohazard procedures, being diligent of any unusual trends in product evaluations. Candidate should be willing to work independently with minimal guidance as well as participate in cross-functional complaint review groups on a regular basis or as requested and collaborate with other employees, customers, contractors, and vendors. In addition, candidate will support the Quality Management System (QMS), Environmental Management System (EMS), and comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
- 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. Knowledge of global regulations for medical device reporting and medical terminology is a plus - 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 geographically diverse business environment - 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
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