Quality System Development Manager

In the role as Quality System Development Manager in Corporate Quality, you will contribute to our purpose of Bringing People Closer. You will oversee and develop the Corporate Quality System in GN Hearing A/S in GN headquarters and support continuous development.

The Team You Will Be Part Of:

You will join the Corporate Quality department, specifically the Quality Systems Team. The team, consisting of 10 people, is focused on maintaining high-quality standards and ensuring compliance across all operations within the business area Hearing (medical devices). We promote a culture of collaboration, continuous improvement, and innovation.

Your contribution is appreciated, and you will:

• Manage and develop the corporate quality system in GN Hearing A/S supported by process owners and Corporate Quality. The system has appx. 1000 users.

• Plan and conduct Internal audits of GN Hearing A/S QMS.

• Plan, host and follow up on notified body-, customer- & authority audits of GN Hearing A/S QMS.

• Conduct Corporate audits, together with the Quality Systems auditor team, on GN Hearing sites all over the world (11 sites with appx. 4000 employees), as well as on contract manufacturer sites in Europe.

• Maintain Notified body basic data and certificates for GN Hearing A/S

• Communicate substantial changes to notified body.

• Coordinate evaluation of local suppliers (including maintaining certificates) in the GN Hearing A/S QMS.

• Be QMS SME for defined processes

• Keep an eye on all relevant GN Hearing A/S QMS activities.

• Maintain E-Learning on Quality & Regulatory requirements for Corporate Quality

To perform well in the role, we imagine that you:

• Have deep knowledge of and extensive experience with handling Quality Systems in medical device companies or pharma companies. (ISO 13485:2016, MDSAP, MDR/IVD, FDA QMSR).

• Are certified ISO 13485 auditor.

• Are MDSAP/MDR trained.

• Possess extensive knowledge in cross-functional collaboration and stakeholder management.

• Are skilled in problem-solving tools.

• Are proficient in English, spoken and written.

We encourage you to apply

Even if you don’t match all the above-mentioned skills, we welcome your application if you think you have transferrable skills. We highly value a mindset and motivation that align with our core values, to not only ensure growth for you, but for your team and the wider GN organization as well.

We are focused on an inclusive recruitment process

All applicants will receive equal consideration for employment. As such, we encourage you to submit your CV without a photo to ensure an equal and fair application process.

How to Apply?

Use the ‘APPLY’ link no later than June 12th. Applications are assessed on a continuous basis, so don’t wait to send yours.

Feel free to only submit your up-to-date CV including a few sentences outlining your motivation for applying – quick and easy.

Join Us in Bringing People Closer:

GN brings people closer through our advanced intelligent hearing, audio, video, and gaming solutions. Inspired by people and motivated by innovation, we deliver technology that enhances the senses of hearing and sight. We enable people with hearing loss to overcome real-life problems, improve communication and collaboration for businesses, and provide great experiences for audio and gaming enthusiasts.

GN Store Nord A/S has entered into a definitive agreement for the sale of GN’s Hearing business to Amplifon S.p.A. to create a global leader in audiology. For GN Group, this creates an opportunity to expand our position in the large audio and video peripherals markets. Read more about the announcement here. 

We hope you will join us on this journey and look forward to receiving your application. 

#LI-GNGroup

#LI-Resound