We are currently partnering with a global Biotechnology company who are searching for a Technical Product Complaint Consultant for a 9-month contract. The position is based in the Zug area and offers some flexibility of home office.
The person will be responsible for collaborating with regulatory and quality functions to align on the interpretation of the requirements ISO13485 and Medical Device Regulation to identify processes to allow proactive collection of customer feedback that will feed into Post Market Surveillance process.
- Provide support to team members on ensuring current implementation of Use error handling which allows correct complaint intake, trending and feedback into specification and risk management in line with the expectations of ISO13485 MDR and combination product Medical Device Reporting and usability requirement.
- Work with customer interfacing teams to establish processes required and ensure implementation in QMS for the applicable Medical Device product in line with the expectations of ISO13485 and EU MDR
- Ensure correct implementation of updated design control and risk management procedures through translating feedback data to design/ risk management documents for medical device and combination device
- Collaborate with quality and regulatory to align on the approach to take going forward
- Strong with customer complaints
Please apply directly!