WORK SHIFT
DAY (United States of America)

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).

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 Post-Market Surveillance Specialists 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 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 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.

ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS

• Lifting -- Not to exceed 50 lbs. - local practice may apply.
• Writing
• Sitting
• Standing
• Bending
• Visual acuity
• Color perception
• Depth perception
• Reading
• Field of vision/peripheral

SUMMARY OF MINIMUM QUALIFICATIONS

• 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

PREFERRED QUALIFICATIONS

• Knowledge of medical product/device use.

COMPETENCIES

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

COMMENTS

Infectious Control Risk Category I:

The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category I states employment and procedures that will require exposure.