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Quality Engineer, Complaint Systems - improve our complaint handling and vigilance reporting processes

Do you want to ensure safe and enriching sound experiences in the future by managing our customer complaint and vigilance reporting processes internationally?

“You will be an important stakeholder in the continuous work improving our complaint handling process and tools, securing on-time documentation and customer satisfaction,” says Quality Assurance Manager Göran Granqvist.

Join the Customer Focus team 
In the Customer Focus team, part of Corporate Quality within GN Hearing, our ambitious and inspiring quality specialists have one steady focus: customer satisfaction. From 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. We are generating information, recommendations and proposals to relevant parts within the GN Hearing organization with the intention to improve product performance and the sound experience of tomorrow. 

Further develop our reporting systems and processes
As our quality engineer in this newly established position, your core responsibility will be to manage the corporate complaint process procedures and the vigilance reporting process, including related procedures and reporting. 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
  • 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 because we contribute to change through what matters most: customer feedback. We listen to their needs for improvement and react to potential vigilance reportable matters,” Göran concludes.

Analytical profile with experience from a regulated industry 
We will come to know you as an organized colleague who takes action and establishes optimal reporting paths for our organization to follow. Your ability to communicate technical and event-related details and statutory demands across functions is key in this position.

Furthermore:

  • You have at least 5 years’ experience in quality assurance and risk management - preferably with handling 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 and QSR
  • 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 speak and write English effortlessly

  
Would you like to know more? 
To apply, use the ‘Ansøg’ link no later than April 19, 2019. 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.

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