Our client is currently seeking a driven and ambitious Product Complaint Coordinator to join their team. This is a unique opportunity for a highly motivated professional who has a go-getter attitude.
1) Co-ordinate with day to day complaint handling operations including complaint pre-screening, complaint closures, completion of complaint handling process and training (both internal and external to the department)
2) Handle the interdepartmental relationships involved with the gathering, compiling and completing all levels of product complaint investigations within regulatory timelines and country requirements including recommending, and implementing process enhancements to improve efficiency, including clinical complaints and material returns
3) Ensure accurate entry of complaints into the complaint handling database (Agile) and completion of complaint investigations including management oversight and review of complaint data from all sources
4) Ensure proper handling of complaint related device returns and subsequent investigation
5) Ensure compliance with Food and Drug Administration (FDA), Organization of International Standards (ISO), Quality System Regulation and other applicable regulatory requirements, as they relate to the complaint handling/CAPA processes
6) Maintain dashboard and performance metrics
7) Ensure that complaints and CAPAs are adequately addressed in a timely and accurate manner
8) Contribute to team effort by accomplishing related duties as requested
9) Complete pre-audit paperwork for customer audits
10) Assist with the management of document control system
More questions? Want to know the Salary range? Keep reading.
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1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Recent experience in the medical device industry is strongly preferred
4) Preference will be given to people have recent experience in data management
Our client provides their employees with support in an environment that promotes growth and success. If you share the same passion, they welcome your application for consideration!
Sterling-Hoffman Life Sciences is the premier recruitment firm in North America for companies involved in the research, clinical development, manufacturing and distribution of drugs and devices that allow patients to live healthier and more fulfilling lives. Leveraging a network of relationships in every major city – including New York, San Francisco, Raleigh-Durham, Chicago, Dallas, Denver and Los Angeles – Sterling-Hoffman Life Sciences is ideally positioned to assist fast growing CROs, pharmaceutical companies, biotech firms and medical device players in their quest to recruit the best people.