Supervisor, Post Market Surveillance

SUMMARY OF DUTIES

• Supervises and is responsible for overseeing complaint evaluations and investigations.
• 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 Post‑Market Surveillance Specialists by interviewing, training, evaluating job performance, disciplining, 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.
• Establishes 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 evaluations and their approvals.
• Assists with Complaint Review Board.
• Establishes and maintains metrics for complaint closure timeliness, complaint initiation timeliness, and any other business metric needed 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.

• Lifting – not to exceed 50 lbs. (local policy may apply).
• Writing, sitting, standing, bending.
• Visual acuity, color perception, depth perception, reading, field of vision/peripheral.

• Bachelor’s degree in a related field or equivalent education/experience.
• 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.

• Knowledge of medical product/device use.

• Interpersonal skills.
• Written and verbal communication.
• Organizational skills.
• Staff training.
• Problem solving.
• Project supervision.

• Multiple shifts and hours to choose from: days, swing (evening), and nights.
• Medical/dental and other insurances (eligible the first of month after 30 days).
  Low‑cost onsite medical clinic.
• Two onsite cafeterias.
• Employee garden and gardening classes.
• Three weeks’ vacation, one week sick‑time, paid holidays.
• 401(k) and health savings account.