As a young and innovative medical device manufacturer, we are rapidly scaling and changing. But quality is always the number one when treating our customers. We need you as a QA officer to ensure our quality, from day-to-day operation to the long run.
Responsibilities
- Developing and implementing regulatory strategy and roadmaps through deep understanding of regulatory / legislative initiatives and the competitive market landscape;
- Providing the regulatory plan, guidance on risk assessment, and required corrective actions to meet regulatory requirements;
- Interact with notified body and medical device certification consultants and provide guidance for the R&D team on e.g. CE Marking, product registrations, and clinical evaluations.
Must Have
- BSc or higher in Electrical or Mechanical Engineering. 2 year or more working experience in QA/RA.
- Working experience in Medical Device (class II) is required;
- MDR experience is required
- Experience in quality management system (QMS) is required.
- Strong communicative and stakeholder management skills
Nice to have
- Experience in Project management within RA. Have a good understanding on project planning and resource allocations is preferred.
- Experience in ISO 13485 is preferred.
- Working experience in prosthetic/orthotic/ orthopedic company is preferred.
What's great about the job?
- Great team of smart people, in a friendly and open culture
- No dumb managers, no stupid tools to use, no rigid working hours
- No waste of time in enterprise processes, real responsibilities, and autonomy
- Expand your knowledge of various business industries
- Create content that will help our users on a daily basis
- Real responsibilities and challenges in a fast-evolving company
What We Offer
Each employee has a chance to see the impact of his work.
You can make a real contribution to the success of the company.
Several activities are often organized all over the year, such as weekly
sports sessions, team building events, monthly drink, and much more
Perks
A full-time position
Attractive salary package.
Trainings
Self selected training
Sport Activity
Play any sport with colleagues,
the bill is covered.
Eat & Drink
Fruit, coffee and
snacks provided.
