- Job Type: Full-Time
- Function: Business Intelligence
- Industry: Digital Health
- Post Date: 11/20/2022
- Website: letsgetchecked.com
- Company Address: 330 W 38th Street, 405, New York, NY 10018, United States
About LetsGetCheckedLetsGetChecked is a virtual care company that offers at-home testing, telehealth services, and pharmacy capabilities.
LetsGetChecked is becoming a global leader in personal health testing. Our medical technology platform provides connectivity between customers and our global network of laboratories. We are enabling customers to order, manage and track their own clinical outcomes through a personal online account.
We are looking for a Complaints Analyst to enhance our growing team with the focus on management of the customer feedback process. The Complaints Analyst is part of the Regulatory Affairs team and will lead the maintenance of the complaints process in-line with Medical Device Manufacturing Regulations for a class 1 medical device, general IVDs and business requirements. The Complaints Analyst investigates, reviews for reportability, analyses and trends, and responds to customer feedback and has the responsibility for ensuring compliance to and driving continuous improvements for processes relating to Customer Feedback.
Responsibilities include, but are not limited to, the following:
Maintenance and monitoring of complaints
Root cause investigation
Ensure all complaint files are updated in a timely manner
Support product design and manufacturing activities
Prepare reports, documents, procedures, specifications and other such technical documents as required
Drives compliance cross-functionally in alignment with the regional objective for collaboration and multi-site ISO13485 certification
What are we looking for?
Education and/or experience equivalent to a bachelor's degree in Life Science, Engineering or related field
A minimum of 2 years’ experience working in a highly regulated Industry (IVD/Medical Device / Pharma)
Knowledge of quality principles as defined in the regulations and the ability to utilise these methods in a manufacturing environment.
Experience in statistical analysis is an advantage.
Excellent interpersonal, and oral and written communication skills.
Must have strong interpersonal skills and the ability to work effectively with others as a member of a team.
Excellent organizational skills and the ability to work under strict time constraints.
Qualification as a QMS Auditor is an advantage.