Quality Management and Regulatory affairs
Auf einen Blick
- Veröffentlicht:13 Januar 2025
- Pensum:40 – 80%
- Vertragsart:Praktikum
- Sprache:Deutsch (Fortgeschritten)
- Arbeitsort:Länggassstrasse 44, 3012 Bern
Company: AirScale
Location: Bern, Zurich, or Remote
Duration: 3-6 months, 40-80%
Job Type: Master Thesis or Volunteer Internship
Company Overview:
AirScale is an early-stage start-up based in the heart of Zurich. We are a small and dynamic team that thrives on innovation and creativity. At AirScale, we firmly believe that every individual has the potential to bring unique ideas to the table. In line with our beliefs, we are committed to giving our team members a platform where they can take responsibility and make a direct impact on our growth and success.
Job Description:
We are seeking a highly motivated and detail-oriented person to join our team for the development of our quality management system (QMS). You will work closely with our external expert from an established company to ensure we meet the international standard specific to the medical devices industry. You will primarily be responsible for preparing the organization for ISO 13485 certification.
Key Responsibilities:
1. Collaborate with business and technical teams to facilitate the implementation of the quality management system across the organization.
2. Perform a comprehensive risk assessment, create a risk matrix, and develop mitigation plans for identified risks.
3. Understand and analyze ISO 13485 requirements and translate them into an actionable plan.
4. Regularly interact with an expert from an established company to learn best practices, ask questions, and ensure effective and efficient progress towards certification.
Qualifications and Skills:
• Currently enrolled in a graduate program in Engineering, Quality Management, or a related field.
• Excellent organizational skills and attention to detail.
• Strong written and verbal communication skills.
• Self-motivated and proactive, with a willingness to take on responsibility and challenges.
• Prior experience or knowledge of ISO 13485 certification process is a plus, but not mandatory.
Our Offer:
• A vibrant and dynamic work environment at the ETH Student Project House, where you can meet various other startup teams.
• Hybrid work model: Work where you want and from where you want.
• The possibility of joining the startup after completing the thesis / internship.
• An opportunity to work directly and learn from industry experts.
• An inclusive team where every opinion matters.
If you are excited about the opportunity to work in a fast-paced, innovative environment, and looking forward to taking on responsibility and challenges, then we would love to hear from you.
Kontakt
Zubi's AirScale