Improvement Specialist, Quality Systems Hearing

Ballerup - Denmark

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

In the role as Improvement Specialist in Corporate Quality Quality Systems at GN Hearing A/S headquarter you will contribute to our purpose of Bringing People Closer.

You will manage and expand our Quality Planning Program co-drive our CAPA system and help ensure a robust and compliant quality culture across GN Hearing globally.

The team you will be part of:

You will join the Quality Systems team within Corporate Quality at GN Hearing. We are a collaborative and supportive team working closely with stakeholders across R&D Operations and Commercial to ensure that our quality system is robust efficient and continuously improving.

Quality Systems Improvement department is a small team that manages the Improvement processes within GN Hearing Quality Management the team we are committed to support our stakeholders we have a high focus on quality commitments requirements ensure compliance to the processes and last but not least; an environment with room for people.

We value transparency curiosity and teamwork. We aspire to make complex quality requirements simple and practical and to act as trusted partners for colleagues around the world.

Your contribution is appreciated and you will:

Manage and develop the Quality Planning Program in GN Hearing A/S headquarter and support implementation of the process across our global organization.
Co-drive and continuously improve theCAPA system ensuring issues are addressed followed up on and used as input for learning and prevention.
Operate and maintain the overallaudit planning cycle including coordination of internal audits and follow-up on findings.
Co-operate theQuality Systems mailbox triaging and coordinating incoming tasks and questions from other departments ensuring timely and clear responses.
Participate inregulatory and external auditsas a representative from Quality Systems and support preparation on-site interaction documentation and follow-up actions.
Work closely with stakeholders across functions and locations helping them navigate our quality processes and translating requirements into clear actionable steps.
Support general operation in Quality Systems contributing to continuous improvement of our processes and tools.

At GN we pride ourselves on encouraging flexible working whenever possible. We trust our people to fulfil their responsibilities to know when in-person collaboration is better than hybrid and to be present when its needed most.

To perform well in the role we imagine that you:

Have deep knowledge of and demonstrated experience with:
ISO 13485
MDSAP / MDR / FDA QSMR Part 820
Regulated quality systems
Are comfortable working with quality management systems audits and CAPA in a regulated environment.
Enjoy planning coordinating and following up on cross-functional quality activities.
Have effective stakeholder management and communication skills and and like to collaborate with colleagues across different functions and countries.
Are organized and detail-oriented but also pragmatic and solution-focused when supporting the business.
It is beneficial if you have experience withCAPA systems internal/external audits or quality planningin a medical device pharma or similarly regulated industry.
Communicate at ahigh level in English both written and spoken.

We encourage you to apply

Even if you dont match all the above-mentioned skills we welcome your application if you think you have transferable 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. Should you have any special requirements for the interview please let the Hiring Manager know upon accepting an invitation to interview.

How to apply

Use the APPLY link no later than March 1st. Applications are assessed on a continuous basis so dont wait to send yours.

You are welcome to submit only your up-to-date CV including a few sentences outlining your motivation for applying.

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 enhance the senses of hearing and sight. We enable people with hearing loss overcome real-life problems improve communication and collaboration for businesses and provide great experiences for audio and gaming enthusiasts.

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

#LI-GNGroup

Required Experience:

In the role as Improvement Specialist in Corporate Quality Quality Systems at GN Hearing A/S headquarter you will contribute to our purpose of Bringing People Closer. You will manage and expand our Quality Planning Program co-drive our CAPA system and help ensure a robust and compliant quality cultu...