Complaints Handling Management

About the role

The Quality System Specialist II will manage activities and procedures associated with complaints concerning client products. This includes managing the complaint handling system, processing customer communications, maintaining complaint files, and responding to customers.

Responsibilities

• Manage the process of the complaint handling system including receipt of complaints from all sources and all in-process steps including data entry.
• Routing the complaint to appropriate locations for further evaluation.
• Entering of the complaint into the complaint handling system.
• Checking for complaint accuracy and correcting information to process the complaint.
• Providing training to personnel involved in the overall complaint process as directed by management.
• Maintaining annual competencies through training and documentation of training.
• Contacting customers or vendors for further information or follow-up.
• Acknowledging customers of receipt and status of the complaint if needed.
• Participating in training classes including but not limited to, product training, regulatory training, compliance training, and any testing involved.
• Maintaining customer relations via multiple means, written, verbal, phone calls, etc.
• Contacting customers as needed to provide updates on outstanding quality issues.
• Reviewing complaints prior to closure for accuracy and appropriateness of the letter content as well as follow-up acknowledgment notices, if required.
• Triaging customer escalations and escalating to business units for response and resolution as needed.
• Performing history checks on previously submitted complaints by customers to ensure they are receiving appropriate closing responses.
• Ensuring that the customer complaint complies with all relevant procedures.
• Demonstrating technical competencies in mechanical, clinical, and functional areas related to all client products and areas.
• Creating and reviewing closing letters for accuracy and ensuring a right-the-first-time approach to customer communications.
• Maintaining expert knowledge of the compliant handling system.
• Providing feedback to management for compliant process improvement opportunities (e.g., complaints systems, final letters, escalations process, etc...).
• Providing training to peers as requested by management.
• Raising any escalated customer concerns to the next level of management.
• Maintaining good documentation practices for each interaction reported by customers.
• Maintaining in-depth knowledge of the company, department, and quality products, processes, and policies.
• Working in close coordination with other teams to meet resolution and quality expectations.
• Working closely with the compliant management team to ensure the compliant process is being followed and meeting all quality and customer needs.
• Assisting multiple functions of the organization to assist with the product compliant handling and/or quality functions.
• Participating in mentoring and training activities.

Requirements

• Bachelor's degree (BA/BS) preferred and/or combination of education and relative experience in lieu of a degree.
• Minimum 1+ years of experience with medical terminology, nursing, clinical, or laboratory knowledge and familiarity with client products.
• Minimum 2+ years of experience in the complaint handling, medical device industry, customer relations, complaint trending, FDA/ISO regulations.