Post Market Surveillance [4 positions to fill]
Location Andover MA
6 months contract to start with
Minimum 5 years professional experience in the applicable role.
Education: Bachelor's degree or equivalent.
Significant leadership skills
Handle the receipt, processing, monitoring, and reporting of product defect complaints,
Make MDR determination, investigate document the all activities creating the summaries of the investigation,
Documented product complaints into the database for trending and analysis and ensured the complaint process was completed in accordance with corporate procedures, follow the complaint file all the way until completion,
Developing professional expertise, applies company policies and procedures to resolve a variety of issues.
Interfaces with Customer Service and customers/patients to gather additional information required for complaint initiation/investigations, including the retrieval of product samples and or durable equipment retrieval for evaluation, ensures that complaints from multiple sources are tracked.
Determines product and incident complaint codes based on the master symptom code severity list.
Applies knowledge of device regulatory requirements in order to support the Post Market Clinical Surveillance reporting process and evaluates complaints for reporting, partners with other departments to resolve product problems and provides feedback to customers as needed, assists with review of the timely coding of completed investigations, closure of all complaint files, and ensures that all pertinent information is contained consistently and uniformly within the file prior to closure,
Performs queries to provide complaint data and ad hoc trend analysis on reported product problems/complaints.
Reviews and complies with the all applicable company policies and procedures, local, state, and federal laws and regulations.
CAPA support in response to audit readiness findings and in preparation for audits.