Ballerup, Denmark
5 days ago
CAPA Manager

In the role as CAPA Manager in Corporate Quality you will contribute to our purpose of Bringing People Closer. You will oversee and develop the CAPA Process in GN headquarters, be manager of the CAPA team and support the continuous implementation across the globe.

 

The Team you will be part of:

You will join the Corporate Quality department, specifically the CAPA Team in Quality Systems. Our team 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 the CAPA team in Quality Systems, Corporate Quality in Headquarter

Manage CAPA Systems and CAPA Process

Ensure CAPA knowledge and governance is continuously enhanced globally

Facilitate regular Global and Headquarter CAPA board meetings

Ensure follow up and measure progress of Global CAPAs

Ensure monitoring of Local CAPAs and manage CAPA handling in Headquarters

Ensure reporting to Monthly Quality Performance Measure (KPIs), Management Reviews, and Quality Boards

Ensure reporting to RPS (Regulatory Product Surveillance Monthly meetings)

Maintain and develop processes and procedures in the corporate QMS, particularly those related to CAPA´s

Ensure relevant stakeholders are familiar with the CAPA system and provide training as necessary

Implement CAPA actions through suitable problem-solving tools (DMAIC, Lean, Fishbone, 5 Why’s) and statistical tools used in CAPA implementation

Act as Module Owner and Super User for the CAPA Module in the QMS suite Smartsolve

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

Have deep knowledge of and extensive experience with handling CAPAs on a strategic, tactical, and operational level within a regulated industry

Possess knowledge in management, cross-functional collaboration, and stakeholder management

Are skilled in problem-solving tools

Have experience handling CAPAs in suitable IT systems

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 March 14th. Applications are assessed on a continuous basis, so don’t wait to send yours.

On a Time Crunch?

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

If you would like to know more about the position, please contact Head of Quality Systems, Kim Glenert on kglenert@gnresound.com

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.

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

#LI-GNGroup

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