Complaint Coordinator

SUMMARY

Works with Complaint Specialist to process and analyze customer complaints in compliance with worldwide medical device regulations such as ISO 13485, Medical Device Directive 93/42/EEC, and those defined in the Medical Device Single Audit Program (MDSAP) such as the US Code of Federal Regulations. Adheres to regulatory standards by performing the following duties.

ESSENTIAL DUTIES AND RESPONSIBILITIES

The essential duties and responsibilities include the following. Other duties may be assigned.

• Represents the company in receiving product incident reports from all sources (customers,

distributors, etc.) and determines if reported incidents are product complaints as defined by national and international regulations.

• Corresponds and provides follow-up regarding product incident reports on behalf of RTI.

• Interacts with customers on a professional level when representing RTI.

• Contributes to product complaint records and database.

• Coordinates and documents complaint investigations.

• Assesses each product complaint for agency/government reporting status and ensures all necessary reports are submitted in a timely manner.

• Confers with Engineering, Validation, and Production about quality issues associated with new,

modified, or existing products or processes.

• Responsible for customer complaint analysis. Disassembles, measures and investigates all returned

complaint samples including associated samples, and prepares documented analysis.

• Performs investigations and root cause analysis on customer complaints.

• Contributes to returned product evaluation trending.

• Attends monthly complaint meeting.

• Conducts CAPA projects as assigned.

• Identifies deadlines and implements methods to comply with responsibilities in a timely fashion.

• Ability to get along with others, follow directions, and work well under stressful conditions.

• Ability to work overtime, meet attendance standards, and meet deadlines.

• Responsible for following company policies and procedures, including but not limited to, Quality

System Regulations, safety/housekeeping, and Quality Management System

SUPERVISORY RESPONSIBILITIES

None

EDUCATION and/or EXPERIENCE

High School diploma or GED required. Medical device experience preferred. Working knowledge of Microsoft Word, Excel, and Access. Knowledge of Instron and similar measurement devices preferred. Good phone skills, knowledge of Process Control and Product Defects.

INTELLECTUAL SKILLS

The intellectual skills described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• Ability to speak, read and write English, bilingual in Spanish a plus.

• Ability to work with minimal supervision.

• Excellent organizational skills.

• Ability to be proactive, take initiative to be productive and recognize and establish priorities.

• Excellent written and oral communication skills.

• Ability to communicate effectively with other departments as well as all levels of management.

• Ability to multi-task and adjust to frequent changes.

• Ability to deal with varying degrees of stress induced by urgent business-related requirements.

• Ability to be tactful, discreet and handle confidential info appropriately.

• Customer service mentality.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• While performing the duties of this job, the employee is occasionally required to stand, walk, sit, use hands, stoop and bend, reach, climb stairs. The employee must occasionally lift and/or move up to 20 pounds. Use of vision is required for document/report inspection/analysis and visual observation of a computer monitor. Use of hearing and speech are necessary for telephone work. Ability to operate standard business and office equipment such as adding machines, copiers, calculators, typewriters, fax machines, etc.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

• The noise level in the work environment is usually moderate. Lighting is usually fluorescent. Heating/Air Conditioning/Ventilation is usually adequate to accommodate the general office population.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.