QMS Specialist

QMS Specialist

WS Audiology A/S

Do you want to join WS Audiology in making wonderful sound part of everyone’s life? And do you have QMS experience from the regulatory world of medical devices?

WS Audiology is looking for a QMS Specialist to handle the maintenance of Quality Management System and act as the local CAPA Officer for the Danish production site to ensure compliance with global regulatory requirements. You will report directly to the QMS Manager and join the Quality organisation in Denmark.

CAPA, identify root causes and participate in audits   

As QMS Specialist, you will act as the local CAPA Officer and work in close cooperation with departments to identify root causes and needed actions. You will monitor and track the status of CAPAs including trending and data analysis. This done in close cooperation with global CAPA officer and other affiliates. Additionally, you will support quality-relevant activities and projects and participate in the global auditor team for local and global audits.

You will share information and cooperate with local teams in the EMEA region and support and give advice regarding training and CAPAs. Furthermore, you will support the maintenance of the training concept, training data, training needs and training activities.

Experience with Quality Management Systems and medical device

To succeed in this position, you hold a relevant educational degree and have previous experience from a Quality role handling QMS and CAPA within the medical device industry therefor knowledge of ISO 13485, 21 CFR part 820, GMP and GDP is preferred. If you have the qualification as internal auditor, it will also be considered as an advantage.

We expect you to have the ability to interact, collaborate across function areas and stakeholders and communicate with these in English.

On a personal level, you are proactive, solution oriented and self-motivated. You possess a structured and process-oriented mind-set and are able to prioritise your work.

WS Audiology welcome you to a world of opportunities. You will be part of a global company that are committed to make a difference and shape the industry with a commitment to unlocking potential through personal and professional development and achieve more as part of a high performance, collaborative, and empowering culture.

The recruitment process is carried out in collaboration with the consulting company Compass Human Resources Group. If you want to learn more about this position before submitting your application, please do not hesitate to contact Research Manager Joan Hemmingsen, Compass on tel.: +45 70 20 12 75. Please submit your CV as soon as possible, if you are interested. Applications will be processed on an ongoing basis. Please note that all enquiries will be handled with confidentiality and that we will reply to the email address from which you send your CV.

WS Audiology combines over 140 years of experience in pioneering better solutions to help people with hearing loss. With a passion for impact, the around 12.000 employees are committed to achieving their purpose: wonderful sound for all. With brands like Signia, Widex, Audio Service, Rexton and Vibe, and with diverse assets across wholesale, retail, online, managed care and diagnostic solutions, WS Audiology are active in over 125 markets. Going beyond together, they achieve annual revenues of around EUR 2 billion.

Deadline for application: As soon as possible
Workplace: Lynge – Allerød, Denmark
Reference: 2205.297
Company: WS Audiology