- Would you like to work with products that actually change the lives of people worldwide and do it in a fast-growing company? Then you may be a good match for our company.
- Right now, we are looking for a dedicated and highly skilled Process Validation Engineer to support our fast-growing business and international expansion.
- You contribute to set-up and maintenance of efficient and secure flow of outsourced manufacturing processes for our implant assortment.
- In your new job, you will be working with-in the daily business organization as well as in the development organization handling operations related activities through outsourced processes.
- The work includes ensuring that critical process parameters concerning manufacturing, assembly, cleaning, packaging and sterilization are defined, planed, documented and executed.
- Drive PFMEA, establishing process validation plans and implement and document all validation activities.
- All in collaboration with our internal and external partners.
- Part of your work will also be focused on carrying trough product and process changes including updating specifications and drawings.
- As this is a new position created to support a growing organisation you will have the opportunity to influence our internal procedures and create new ways of collaborating with our partners.
- Team wise, you can look forward to joining the Operations team consisting of 5 dedicated and highly skilled colleagues.
- The team is responsible for all aspects of the process from manufacturing set-up to returns.
- Besides your closest colleagues you will also be working closely together with other functions and external partners in different projects.
- We are looking for someone with a passion to work with manufacturing process, set-up, maintenance and improvements.
- Basically, you have an engineering degree with basic knowledge in 3D CAD modelling.
- We prefer that you have experience regarding process validation in the medical device industry, GMP and ISO 13485.
- You are stimulated by building relationships and implementing improvements and new processes as well as working in cross functional teams with your colleagues.
- Your professional style is characterized by your ability to work structured and focused in a technical and professional manner
- Besides that, we expect that you are 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
- Besides the above mentioned, we prefer flexible candidates who can travel up to 40 days per year.
- 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.