Jr. Quality Officer

Delft, Netherlands

As a young and innovative medical device manufacturer, we are scaling and changing very fast. But quality is always the number one when treating our customers. We need you as an QA office to ensure our quality, from day to day operation to long run. 

Regulations
Norms
Autonomy
Administrative Work
Technical Expertise

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. 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
Our Product

Discover our products.

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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.