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Spec 2, Complaint Mgmt - Franklin Lakes New Jersey
Company: Katalyst Healthcares and Life Sciences Location: Franklin Lakes, New Jersey
Posted On: 05/03/2024
Responsibilities: - 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.
- bility 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.
- ble 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 Requirements:
- Knowledge of Quality System standards and regulations including 21 CFR 803 & 820, ISO 13485 and Canadian Regulations desired
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