Quality Improvement (CAPA) Engineer for Corporate Quality

GN Hearing
Ballerup - Denmark
Published: November 06, 2018
Would you like to drive quality improvement in a global organization? And do you want a role where you can work with the latest technologies and a collaborate with colleagues across functions and borders?

In order to make sure we keep getting better, quality improvements and non-conformity handling is managed in a formal process of corrective and preventive actions (CAPA). As CAPA Engineer you are tasked to follow up and measure progress of corporate CAPA cases as well as develop and maintain related processes.

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 19 colleagues. In addition, you will collaborate with colleagues across the entire global GN Hearing organization, 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 follow up corporate CAPA cases throughout the GN Hearing organization, 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 corporate CAPA cases are logged and driven at the local and the global level
• Prepare and facilitate CAPA decision board
• CAPA performance is documented correctly and progress monitored
• All relevant stakeholders are familiar with the CAPA process and trained if necessary
• GN Hearing processes are updated and compliant – and, if necessary, ensure that the process is adjusted to meet legislation

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

Make ideas come to life
As part of a growing organization, 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 organization.

“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.

QA 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 organized, and you know how to motivate and collaborate with a wide range of various internal and external stakeholders, cross-functionally and internationally. Moreover, you bring:

• A degree in a technical subject
• Minimum 5-10 years of quality assurance within a regulated industry, preferably in Medical Devices
• Knowledge of Quality systems and quality engineering techniques
• Experience with risk management and root cause analysis
• Project management skills
• Fluent English in speech and writing

Would you like to know more?
To apply, use the ‘APPLY’ link no later than 30 Nov 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.

For the purpose of processing your job application, GN will process your personal data. We encourage you not to provide us with sensitive information (e.g. racial or ethnic origin, political opinions, religious or philosophical beliefs, trade union membership, health information, or sexual orientation) about yourself. Your application will be transferred to the local GN office posting this job. For information about how GN processes your personal data, please read our » privacy policy