Quality Assurance Specialist

4 weeks ago

Sparks Glencoe, United States Katalyst Healthcares and Life Sciences Full time
Job Summary

We are seeking a highly skilled Quality Assurance Representative to join our team at Katalyst Healthcares and Life Sciences. As a Quality Assurance Representative, you will be responsible for ensuring the quality and compliance of our medical devices, as well as providing exceptional customer service to our clients.

Key Responsibilities
  • Communicate with distributors to collect customer information and maintain accurate records.
  • Conduct administrative activities such as faxing, mailing, and filing of recall notifications.
  • Maintain customer information and facilitate the replacement process with customer service and/or field service.
  • Conduct recall effectiveness checks and interact with external customers in the field action process from inception to completion.
  • Resolve customer concerns by pinpointing problems and offering best courses of action.
  • Document information in our system and communicate directly with the Quality Team to answer specific questions regarding complaints and replacement product shipments.
  • Triage complex customer inquiries, understand the appropriate parties to resolve, and minimize the number of hand-offs for the customer.
  • Ensure compliance with all Client policies and procedures and route calls to appropriate departments for further assistance.
  • Make outbound calls to verify if corrective action notifications have been received and maintain detail records of outbound calls.
  • Provide training to personnel involved in the overall complaint process as directed by management.
  • Participate in all training classes, including 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.
  • Demonstrate technical competencies in mechanical, clinical, and functional areas related 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 and provide training to peers as requested by management.
  • Raise any escalated concerns to the next level of management.
Requirements
  • 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.
  • 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.
  • 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.

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