QA specialist, Complaint Systems
Do you want to ensure safe and enriching sound experiences by managing
QA specialist, Complaint Systems - improve our complaint handling and vigilance reporting processes
Do you want to ensure safe and enriching sound experiences by managing our customer complaint and vigilance reporting processes internationally?
“You will play an important role in our work to improve our complaint handling process and tools, securing on-time documentation and customer satisfaction,” says Quality Assurance Manager Göran Granqvist.
Welcome to the Customer Focus team
Our team is part of Corporate Quality within GN Hearing, and our specialists have one steady focus: customer satisfaction. At our HQ in Ballerup, we work with post-market surveillance data gathered from end users, hearing care professionals, authorities and parts of the GN Hearing organization. With the goal of improving product performance and sound experience, we generate information, recommendations and proposals to relevant parts within the organization.
Develop our reporting systems and processes
As our QA specialist, your core responsibility will be to manage the corporate complaint process procedures and the vigilance reporting process. Incoming complaints primarily come from hearing care professionals worldwide.
More specifically, you will:
- Maintain and improve our complaint reporting process and systems to ensure solid statutory documentation
- Monitor authorities through the Country Medical Device Reporting databases for incoming reportable issues from our competitors to get a heads-up about issues we can learn from
- Drive and coordinate possible vigilance reporting to authorities
- Coordinate potential safety-related complaints
- Collaborate with e.g. R&D to contribute to the improvement of future devices
- Train and keep our organization updated on systems, processes and tools both on site and via Skype
- Give input to our Post Market Surveillance Process about monitoring and trending issues, including possible vigilance reports
“As a team, we make a difference every day by contributing to change through what matters most: customer feedback. We listen to their needs and react to potential vigilance reportable matters,” Göran concludes.
Highly analytical with quality assurance experience
It is key that you are able to communicate technical and event-related details and statutory demands across functions. You are very organized, enabling you to establish optimal reporting paths for our organization to follow. Moreover, it is an advantage if you have a clinical or an audiology background. Finally:
- You have at least 5 years’ experience in quality assurance and risk management, including handling safety complaints and vigilance reporting - and you come from the medical device, pharmaceutical or a similarly regulated industry
- You are preferably trained in medical device standards, ISO 13485, QSR and MDR 2017/745
- You hold great stakeholder management skills and have the ability to collaborate with various internal and external stakeholders across borders and cultures
- You have the ability to travel up to 20 days a year to our subsidiaries worldwide
- You are fluent in English and capable of writing reports in an appropriate academic language
Would you like to know more?
To apply, use the ‘Ansøg’ link no later than January 1, 2020. Applications are assessed on a continuous basis, which is why we encourage you to send your application as soon as possible.
If you want to know more about the position, you are welcome to contact Quality Assurance Manager Göran Granqvist on +45 5336 4319.
Please write in your application that you've seen the job at Jobfinder.