Quality Officer

2 maanden geleden

Delft, Nederland Reboocon Bionics Voltijd

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.

**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 in Electrical or Mechanical Engineering.
- Understanding MDR and 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.

**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.

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