Job Title: Quality Specialist (Post-Market Surveillance-Medical Device)
Pay: $19.00 - $21.00/hour
Job Overview: Provides clinical and safety data assessment of post-marketing events. This position plays an integral role to maintain compliance with global regulations. Works with minimal supervision and requires a high degree of interaction with customers, health care professionals, global government agencies and Global company employees at all levels within the organization.
Essential Duties and Responsibilities:
- Field inquiries received by phone, electronic or verbal correspondence and document reported complaints according to applicable SOP(s).
- Review associated records; provide technical guidance, and contact users and customers to collect information on the treatment, product performance, functionality, etc.
- Conduct periodic follow-up to close complaints in a timely manner.
- Complete investigations, which may include execution or coordination of product returns and subsequent evaluations, review of manufacturing records and ensuring proper approvals are obtained as part of closure.
- Evaluate complaints and determine if the submission of a Medical Device Report (MDR) or other Vigilance Report is required. Additional responsibilities may include submitting MDRs and Vigilance Reports according to regulatory timelines.
- Monitor the FDA’s MAUDE data base and provide quarterly reports of activity for management review.
- Recommend and implement operational changes to improve efficiencies in all aspects of complaint handling.
- Support statistical analysis of complaint trends.
- Maintain awareness of changes to global regulatory requirements related to complaint handling and adverse event reporting.
Internal – All departments. External – Service Vendors, Customers, distributors, patients, regulatory bodies.
- BS in Science, such as Engineering, Chemistry, Biology, etc.
- Fresh grads encouraged to apply.
- Competent in identifying and responding to priorities and managing complaint related reports that must be submitted by remote sites and/or sales staff.
- Knowledge of, and competent with, administrative and clerical procedures and systems such as word processing, managing files and records, designing forms, and other office procedures and terminology. Solid grasp of Medical Terminology and competence with the English language as well as word definitions, composition, and grammar is required.
- Ability to establish priorities, work independently, and proceed with objectives with minimal supervision. Ability to manage multiple priorities.
- Handle communications with customers and patient information with tact and handle confidential information with discretion