Quality Assurance Complaints Handling Specialist

• Under the direction of PMQ Field Action Manager, the Quality Assurance Representative, will interact with internal and external customers to provide and process information in response to inquiries, concerns and requests pertaining to products and services.
• The Quality Assurance Representative will also act as a liaison supporting customers through the complexity of multiple business and department infrastructures focusing on business-critical items while meeting the goals, objectives, and demands of the organization and adhering to policies and procedures.
• The key customer-facing activities include case creation for more complex scenarios, inbound/outbound calls, efficient/effective handling and resolution of escalated issues and queries, as well as supporting customer relationships within assigned business specialty areas.

• Executes the logistical processes for client field actions, including but not limited to:
• Communicating with distributors to collect customer information.
• Conducting all administrative activities such as faxing, mailing, and filing of recall notifications.
• Maintaining customer information.
• Facilitating the replacement process with customer service and/or field service.
• Conducting recall effectiveness checks.
• Interacts with external customers in the field action process from inception to completion.

• Resolving customer concerns by pinpointing problems to offer best course of action and following up to ensure customer satisfaction.
• Must be able to maintain a positive image when interacting with customers.
• Excellent communication skills required, as well as a high level of patience, understanding, and tact, often under difficult circumstances.
• Document information in system
• Communicate directly with Quality Team to answer specific questions regarding complaints and replacement product shipments being sent back for a quality assessment.
• Ability to triage complex customer inquiries, understand the appropriate parties to resolve, and minimize the number of hand-offs for the customer.
• Ensures compliance with all client policies and procedures
• Routing the calls to appropriate departments for further assistance.
• In the event multiple departments are involved, take on the task to resolve then call back the customer.
• Make Outbound calls to various customers to verify if corrective action notifications have been received.
• Able to navigate through large medical facilities to identify correct party to acknowledge corrective action notices.
• 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.
• Maintains annually competencies through training and documentation of training.
• Interact with cross-functional teams as needed, regarding any questions related to the complaint file.
• Demonstrate technical competencies in mechanical, clinical, and functional in relation to all client products and areas.
• Remain current in product knowledge and any upgrades to complaint handling systems.
• Maintain expert knowledge level of the compliant handling system
• Provide training to peers as requested by management.
• Raise any escalated concerns to the next level of management.
• May perform other duties as required

• 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

• Ability to take ownership and think independently, with minimal supervision.
• General knowledge of producing metrics and building reports.
• Strong analytical, deductive reasoning and listening skills.
• Must be able to communicate precisely and accurately to all levels of the organization.
• Strong interpersonal skills.
• Strong Project management skills.
• Demonstrated aptitude for identifying creative solutions to complex customer issues’ ability to “think outside the box”
• Excellent time management and multitasking skills.
• Excellent written and verbal communication skills.
• Works well in a team environment.
• Strong personal commitment to quality, customer service and patient safety.
• Must be motivated, self-directed and able to work with minimal supervision.
• Continuous and versatile learner

• 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.

MillenniumSoft