.Johnson & Johnson - Abiomed is recruiting for a Team Lead Post Market Complaint Handling!
This position will be located in Danvers, MA!
At Johnson & Johnson, we believe health is everything.Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.This role is part of Abiomed's Post Market Surveillance program inclusive of Regulatory reporting.
Our Regulatory reporting program is designed to meet FDA's Quality system Regulation (QSR/Good Manufacturing Practices(GMP) and globally harmonized standard ISO as well as any global regulatory standards based on product geography.Key Responsibilities:Responsible for operational aspects of the team including workflow, performance, and compliance.Supervises individual contributors and conducts effective performance management.Coordinates processes and assignment of daily work for the team.Assists in the review of the use of systems to ensure document standards are maintained.Assists with implementation of process changes and procedural updates.Analyze and process complaints in a uniform and timely manner, to ensure proper complaint coding and accurate complaint assessment.Ensures close partnerships with upstream and downstream customers to identify risks and improvement opportunities.Completes assessments of product complaints to determine reportability and coordinates complaint investigations between the quality assurance department, engineering, customer support, and other departments.Support investigations and review of potential adverse events.Perform data entry and prepare reports/graphs related to special projects, complaints, and lot qualification as necessary.Process feedback letters and communications with various reporting sites.Escalate complex complaint issues per department policies and guidelines.May prepare and/or review regulatory submissions and complete international vigilance reports of adverse events as required.Evaluates and confirms information from a technical perspective to ensure appropriate analysis, investigation, and that the root cause is documented prior to complaint closure.Partners with appropriate functional departments to achieve effective corrective action on severe and/or recurring problems.Qualifications:Education: Bachelor degree or equivalent combination of education and experience with a minimum of 2+ years' experience with data management, record keeping, and troubleshooting in the Medical Device field, or other transferable experience related to organization, technical aptitude, and data management.Experience and Skills:Required:Maintain Abiomed's Post Market Surveillance documentation per Abiomed procedures and Regulatory requirements to stand on its own in the event of an audit.Comply with all regulatory requirements, company policies, operating procedures, processes, and task assignments