Supervisor, Post Market Surveillance

Merit Medical Systems, Inc.•South Jordan, UT

22h

About The Position

At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world. WORK SHIFT DAY (United States of America) SUMMARY OF DUTIES Supervises and is responsible for complaint intake, receiving, complaint coordination, and complaint closures. Works with internal and external customers to ensure proper handling and documentation of reported complaints. Works closely with the Clinical Quality team to ensure on time reporting of complaints to regulatory authorities (when applicable). ESSENTIAL FUNCTIONS PERFORMED Ensures that company procedures (GP, GPS, QSP, etc.) and regulatory standards (FDA, CFR, MDR, ISO, etc.) are followed with respect to assigned areas of responsibility. Supervises Quality and Field Assurance technicians by interviewing, training, evaluating job performance, discipling, scheduling work and other related responsibilities. Works closely with Sales Representatives and customers to clarify, obtain, and/or better understand the reported information in relation to product complaints. Performs follow-up in the form of emails or calls to obtain additional information relating to product complaints. Provides training to employees on Merit’s complaint handling process. Establish relationships and builds confidence among staff, physicians, Sales Representatives, and other customers. Ensures customer complaints are well documented and compliant with applicable regulatory standards. Responsible for Corrective Preventive Actions (CAPA); including investigations and resolving issues and determining course of action. Responsible for complaint associated product receipts and product decontamination. Leads Complaint Review Board. Establishes and maintains metrics for complaint closure timeliness, complaint initiation timeliness, and any other business metric need around complaint handling. Identifies and records any product, process and quality system problems. Acts as the Subject Matter Expert on complaint handling and Merit’s process for internal/external audits. Makes presentations at and/or attends local, regional, and national meetings requiring complaint handling expertise, knowledge, and experience. Escalates to the Sr. Manager of Global Complaint Handling if problems arise. Performs other duties and tasks as required.

Requirements

Education and/or experience equivalent to a Bachelor's degree in a related field.
A thorough understanding of customer service practices.
Demonstrated experience applying analytical and problem solving skills to understand and solve complex issues.
Ability to train employees
Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs.
Knowledge of NC/CAPA causes/corrective actions/dispositions

Nice To Haves

Knowledge of medical product/device use.

Responsibilities

Supervises and is responsible for complaint intake, receiving, complaint coordination, and complaint closures.
Works with internal and external customers to ensure proper handling and documentation of reported complaints.
Works closely with the Clinical Quality team to ensure on time reporting of complaints to regulatory authorities (when applicable).
Ensures that company procedures (GP, GPS, QSP, etc.) and regulatory standards (FDA, CFR, MDR, ISO, etc.) are followed with respect to assigned areas of responsibility.
Supervises Quality and Field Assurance technicians by interviewing, training, evaluating job performance, discipling, scheduling work and other related responsibilities.
Works closely with Sales Representatives and customers to clarify, obtain, and/or better understand the reported information in relation to product complaints.
Performs follow-up in the form of emails or calls to obtain additional information relating to product complaints.
Provides training to employees on Merit’s complaint handling process.
Establish relationships and builds confidence among staff, physicians, Sales Representatives, and other customers.
Ensures customer complaints are well documented and compliant with applicable regulatory standards.
Responsible for Corrective Preventive Actions (CAPA); including investigations and resolving issues and determining course of action.
Responsible for complaint associated product receipts and product decontamination.
Leads Complaint Review Board.
Establishes and maintains metrics for complaint closure timeliness, complaint initiation timeliness, and any other business metric need around complaint handling.
Identifies and records any product, process and quality system problems.
Acts as the Subject Matter Expert on complaint handling and Merit’s process for internal/external audits.
Makes presentations at and/or attends local, regional, and national meetings requiring complaint handling expertise, knowledge, and experience.
Escalates to the Sr. Manager of Global Complaint Handling if problems arise.
Performs other duties and tasks as required.