Job Type: Permanent
Magenta have an exciting new opportunity, working with an ever growing Medical Device manufacturer who are seeking a QA Specialist to join their team. The purpose of this position is to ensure that the companies complaint procedures are adhered to the correct regulatory requirements.
- Receiving and recording information relating to customer feedback and complaints;
- Evaluating information to determine if the feedback constitutes a complaint;
- Logging incoming Performance evaluation reports into the management system
- Participating in and documenting complaint investigations, root cause analysis and corrective action plans;
- Ensuring complaint handling records are clear; concise; and adhere to internal and regulatory requirements.
- Supporting notification and follow-up of complaints that meet specified reporting criteria of adverse events or issuance of advisory notices within regulatory time scales
- Maintaining records of reporting to regulatory authorities
- Ensuring follow up and complaint management activities are performed in a timely manner
- Handling of complaint-related product;
- Maintaining minutes of Complaint reviews and associated meetings
- Experience in the medical device industry in a Quality or regulatory capacity
- Auditing experience