The Product Experience Coordinator is responsible for interacting with customers to provide information in response to inquiries about products, services, and to participate in the resolution of customer complaints. This includes the intake, follow-up, and system entry. Complaint handling accountabilities reflect activities required to comply with local and international regulations, guidelines, and applicable directives. Qualified candidate will be a experienced person who has the following attributes: great follow up with customers-systems based person, ISO 13485 Quality Management System experience, attention to detail, and able to adapt to a dynamic environment.
Essential Duties and Responsibilities
Receive initial complaint from any source and assure all information is accurately captured at point of contact.
Maintain an understanding of information required to be collected for technical and reportable complaints to assure compliance with regulations and directives.
Is aware of the global marketspace that ZPower supports.
Performs intake / follow up / data entry activities and attaches corresponding source documents in a timely manner per requirements and directives.
Assigns degrees of urgency from all sources for quality complaints, adverse event, and request for refund, replacement of product and credit.
Reviews data entry and follow-up activities for completeness and timeliness of complaint cases.
Closes files according to established guidelines to meet required timelines.
Understanding of reportable events and vigilance reports per local and international regulations.
Job Specific Competencies
Experience within the Medical Device Industry with exposure to ISO 13485.
Experience with the FDA’s 21CFR Part 820.198 Quality System Regulation, Complaint Files.
Experience with application of regulatory requirements and ensuring company compliance with regards to customer complaints.