Spec 2, Complaint Mgmt.

3 weeks ago

Sparks Glencoe, United States Katalyst Healthcares and Life Sciences Full time
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.
  • Product knowledge: understanding of product usage and the ability to differentiate between significant and non-significant health risks to either patient or healthcare worker.
  • bility to handle complex customer inquiries and receive, review, and process purchase orders.
  • bility 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.
  • bility 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
  • 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.

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