Junior QA/ra Officer M/w/x

il y a 2 semaines


Elsene, Belgique HASA OPTIX Temps plein

**Description de l’entreprise
**HASA OPTIX is a Brussels based medical device company that creates and produces high quality recyclable surgical ophthalmic instruments. We offer high quality single-use devices with specific care about the planet resources. To safeguard the future of our planet the company focuses on sustainability by delivering recyclable single-use instruments. Our job is to equip hospitals and medical professionals with precision-engineered instruments, facilitating their work and contributing to the patient's well-being. No matter where in the world you are based, our representative is close by. We deliver to all corners of the world.

**Description de la fonction
**What will you do?**
- Provide Quality management and Regulatory affairs leadership across the business within a highly regulated medical device environment including conducting the company MDR transition
- Manage the relationship with our external teams (Notified Body, consultants, waste management companies, universities, etc. ).
- Assist our QA/RA Manager in daily tasks and, short-term + long-term, projects

**Description du profil
**Requirements**:
Sounds like something for you? You would be a great fit if you have:

- An Entrepreneurial spirit, can-do attitude, autonomous, solution-oriented, and strong emotional intelligence
- A 2-to-5-year experience in a Regulatory/Quality role including negotiating with regulatory authorities
- A strong motivation for sustainability solutions and/or a proven track record in that field
- Excellent knowledge of MDD/MDR regulations as well as ISO 13485 (class Ila devices)
- Are data-driven and analytical, highly organized and detail-oriented
- Strong communication, analytic and interpersonal skills: you will be communicating intensively with distributors as well as other stake holders
- Ability to manage projects and timelines, following up with key stakeholders
- Languages: Business English (verbal and written) + other European languages are a plus
- Experience in medical device or ophthalmology is an asset
- Motivation to join a dynamic medical device early stage growing small team

**Avantages du poste
**You will be part of an enthusiastic team. We believe we have the make-it-happen attitude of a start-up with the resources of a scale-up. We constantly look for new ideas and ways to do our work differently. If you want to try or launch something new, you just can. Our QA&RA activities as well as our cradle2cradle program are N°1 priorities; you will have the necessary resources to stay up to date and work with the latest digital tools & techniques. We are looking for adventurous, hands-on "intrapreneurs" to be part of our ambitious expansion project. We offer:

- The opportunity to have fun, learn, grow in a challenging environment, and hopefully be part of history
- The opportunity to be part of a disruptive process improving care for patients through medical device sustainable solution
- A strong dedication to employee well being and team spirit
- Strong network opportunities
- Additionally, an appropriate financial contribution, diner cheques, eco cheques, a yearly bonus, multiple trainings and daily organic free lunch with team and company e-bike

**Informations supplementaires**
Lieu de travail Ixelles, Belgique

Type de contrat : Travail


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