QMS Specialist, Local CAPA Officer Quality · Lynge, Denmark

WS Audiology
Formed in 2019, through the merger of Sivantos and Widex, WS Audiology combines over 140 years’ experience in pioneering the use of technology to help people with hearing loss hear the sounds that make life wonderful. We are active in over 125 markets and employ 12,000 people worldwide. Our broad portfolio of hearing related products and services generates annual revenues of above EUR 2 billion. Learn more about us on www.wsa.com

The Role
WSA Audiology wants to continue delivering on their purpose making wonderful sound part of everyone’s life and are strengthening their capabilities with an additional passionate and purpose-driven team player in the Quality organisation. WS Audiology is now looking for a QMS Specialist to join the Quality Management System team based in Danish headquarter.

As QMS Specialist, you will be responsible for the maintenance of the Quality Management System on a local and regional level to ensure compliance with global regulatory requirements. Moreover, you will be acting as the local CAPA Officer.

Your responsibilities include, but are not limited to:

• Acting as local CAPA Officer with close cooperation with departments and stakeholders.
• To work with departments to identify root causes and needed actions.
• To monitor and to track the status of CAPAs including trending and data analysis.
• Cooperate closely with global CAPA Officer and other affiliates.
• To support in quality-relevant activities and projects.
• Participate in the global auditor team for local and global audits.
• Have close cooperation and information sharing with local teams in affiliates in EMEA region, supporter and giving advice in regard to training and CAPAs.
• Support EMEA affiliates in the maintenance of the training concept according to global and local requirements, additional local regulatory requirements and according to ISO 13485, as well as to ISO 14001/45001 if needed. This done in close cooperation with all departments in all topics regarding training data, training needs and training activities.

Candidate Profile
As a person, you are motivated by seeing the results of your work as well as engaging with others to create them. You are robust, diligent, curious, and impactful. Your approach is self-starting, and you convincingly engage stakeholders on all levels of the organization, from senior management to sales representative.

Experience

• Solid knowledge of GMP, ISO 13485, 21 CFR part 820, GDP
• Qualification as internal auditor
• Excellent Process Management Skills
• A skilled presenter with hands-on training capabilities
• Team Player with good communication
• Good command of English both written and spoken

It would be a plus if you also have:

• Experience in People Management, Functional Organization Management
• Experience in Statistical Data Analysis or similar
• Affinity for working with IT tools

Join WS Audiology

We offer exciting tasks and career development opportunities where you exercise great personal influence on the direction you wish to take, ranging from global opportunities to exploring different functional areas. Through successful deliverables and exposure to Group Management members and country leaders, you will find that our unit offers attractive career opportunities.

We will be conducting interviews on a continuous basis, so please send your CV and application as soon as possible.

Department
Quality

Role
Quality Management System

Locations
Lynge, Denmark