You ensure implementation and maintenance of the Quality Management System.
In your new job, you will be responsible for maintaining the quality management system and supporting the organisation in quality compliance.
This includes but is not limited to:
- Preparing, implementing and supervising the compliance of quality procedures
- Co-hosting external audits
- Drive quality system projects incl alignment with sister companies and implementation of new standards and regulations influencing QMS (like ISO 13485, MDSAP, MDR)
- Perform QMS trainings of the organisation
- Perform internal audits and audits of subcontractors and distributors
- Complaints and CAPA handling
As this is a new position created to support a growing organisation you will have the opportunity to influence the role depending on your skills.
- We offer you the opportunity to join an enthusiastic team focused on the continued growth and expansion of our company.
- You can look forward to joining the QA/RA team consisting of 3 dedicated and highly skilled colleagues.
- The team is responsible for the quality management system and all regulatory aspects related to our products.
- Besides your closest colleagues you will also be working closely together with other functions in different projects.
- You will be reporting to the Senior Director QA/RA & Operations
- We are looking for someone with a passion for efficiency, structure and compliance and understand the challenges of working in a fast-growing environment
- You should have worked at least 3 years with quality and regulatory in a medical device company, preferably class III products.
- Basically, you have thorough understanding of AIMDD, MDD, ISO 13485 and QSR
- You are an outgoing and positive team player who can work structured and independently coordinating your own work but also by working as a team in a cross functional project with your colleagues.
- Your professional style is characterized by your ability to work structured and focused in a technical and professional manner - no matter the deadlines or the pressure you experience.
- Besides that, we expect that you re pragmatic and strive for efficiency in all that you do
- Think and act holistically and like to take responsibility
- Skilled in creating and maintaining good relations to all parts of the organization Know how to benefit from multi-site and multi-cultural development teams
- 500 million people worldwide suffer from hearing loss.
- It is our ambition that our customers - hearing clinics throughout the world - prefer to use our products for people with impaired hearing.
- Our company is one of the two largest companies in the industry, and in Denmark all 1,300 employees, with passion, dedication and professional expertise, develop some of the most innovative hearing aids in the world.
- Our company is an international growing company, and 98% of Group revenues is generated outside Denmark.