CAPA Engineer for Corporate Quality

GN Hearing
Ballerup - Denmark
Published: May 03, 2018
Would you like to drive quality improvement in a global organisation? And do you want a role where you can work with the latest technologies and collaborate with colleagues across functions and borders?

As our first CAPA engineer, you are tasked with developing and monitoring the formal process around necessary corrective and preventive actions (CAPA) to make sure we keep getting better.

Join Corporate Quality at our Danish HQ
At our Danish HQ in Ballerup, Denmark, you will join our Corporate Quality department where you will work alongside 16 colleagues. In addition, you will collaborate with colleagues across the entire global GN Hearing organisation, including R&D, Global Marketing, Global Operations, Sales, Quality and local manufacturing sites.

Establish and drive a corporate CAPA process
As a CAPA engineer, you coordinate all CAPA cases throughout the GN Hearing organisation, ensuring progress and structure and staying updated on any issues. You act as an advisor to GN manufacturing sites and QA colleagues and keep all stakeholders updated on the progress within regulatory, compliance and process issues related to R&D, Global Operations, Sales, Marketing and Quality. As the CAPA process plays an important role in documenting compliance towards regulations, you will also be involved in preparing internal and external audits.

Keeping a global overview, you ensure that:

• All CAPAs are logged and driven at the local and the global level
• A CAPA decision board is prepared and facilitated
• CAPA performance is documented correctly and progress monitored
• All relevant stakeholders are familiar with the CAPA process and trained if necessary
• GNH processes are updated and compliant – and, if necessary, ensure that the process is adjusted to meet legislation

As you collaborate with quality assurance managers globally, you will have up to 20 days of travel per year to Europe, the US and sites in Asia.

Make ideas come to life
As part of a growing organisation, you will work in a global environment where great ideas are brought to life quickly. Together with your team, you make a global imprint on the organisation.

“You will join a team of colleagues who aren’t just happy to get to work with the latest technologies – we take pride in contributing to the mission to make life sound better for our end users,” says Head of Strategic Quality Planning Per Castensson.

CAPA experience and a flair for project management
We are looking for a CAPA engineer who is self-driven, analytical and structured as well as a strong communicator and an influencer. You have a flair for keeping things organised, and you know how to motivate and collaborate with a wide range of various internal and external stakeholders both cross-functionally and internationally. Moreover, you bring:

• A degree in a technical subject
• Minimum 5-10 years of CAPA experience and/or complaint management within a regulated industry, preferably in medical devices
• Knowledge of quality systems and/or quality techniques
• Experience with risk management techniques
• Speak and write English fluently

Would you like to know more?
To apply, use the ‘APPLY’ link no later than 31 May 2018. 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 Head of Strategic Quality Planning Per Castensson on +45 5336 4348.

About GN Group
The GN Group is a global leader in intelligent audio solutions that let you hear more, do more and be more than you ever thought possible. With our unique competencies within medical, professional and consumer audio solutions, we transform lives through the power of sound: Hearing aids that enhance the lives of people with hearing loss; integrated headset and communications solutions that assist professionals in all types of businesses to be more productive; wireless headsets and earbuds designed to support calls, music and media consumption.

With world leading expertise in the human ear, sound, wireless technology and miniaturization, GN’s innovative and intelligent audio solutions are marketed by the brands ReSound, Beltone, Interton, Jabra and Blueparrott in 100 countries across the world.

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