Quality Assurance Complaints Handling Specialist

Job Summary

The Quality Assurance Complaints Handling Specialist will interact with internal and external customers to provide and process information in response to inquiries, concerns and requests pertaining to products and services. They will act as a liaison supporting customers through the complexity of multiple business and department infrastructures.

Responsibilities

• Interacts with external customers in the field action process from inception to completion.
• Resolves customer concerns by pinpointing problems to offer best course of action and following up to ensure customer satisfaction.
• Maintain detail records of outbound calls such as representative names, titles, disposition of any products.
• Provide training to personnel involved in overall complaint process as directed by management.
• Participates in all training classes including but not limited to, product training, regulatory training, compliance training and any testing involved.
• Maintain annually competencies through training and documentation of training.
• Interact with cross-functional teams as needed, regarding any questions related to the complaint file.
• May perform other duties as required.

Requirements

• Knowledge of Quality System standards and regulations including 21 CFR 803 & 820, ISO 13485 and Canadian Regulations desired
• Product knowledge: understanding of product usage and the ability to differentiate between significant and non-significant health risks to either patient or healthcare worker.
• Ability to handle complex customer inquiries and receive, review, and process purchase orders.
• Ability to work with customer system administrators and clinicians
• Proven ability to maintain a professional demeanor when handling complex user issues and high-pressure situations.
• Excellent customer service skills: high level of interpersonal skills to interact with peers and management; strong attention to detail; excellent organizational skills; ability to handle multiple tasks simultaneously; and ability to maintain confidentiality

Qualifications

• BA or BS degree preferred and/or combination of education and relative experience in lieu of a degree
• Licensed Medical Professional desired such as Registered Nurse (RN), Med Technologist, Biomedical Engineer
• 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