Our customer is active in the supply of high-quality products and services for laboratories. We are looking for a QA specialist near Fribourg.
Your impact
- As a QA Specialist, you are the subject matter expert for one or more QA processes.
- You will ensure that these processes comply with standards and are deployed appropriately, and provide support to users. You will monitor their performance through key indicators and be responsible for their continuous improvement.
- As a QA business partner, you will be the main point of contact for a department of stakeholders, helping them with all quality-related issues.
- You will evaluate and approve change requests, conduct investigations and follow up on deviations and CAPAs.
- You will conduct internal audits, coordinate site inspection activities and participate in supplier audits.
- You produce training material and organize training sessions relating to our quality management system.
- You manage projects as a project leader and support others as a quality partner.
Profile
• You have a Bachelor’s Degree, Master’s Degree or qualification from a University of Applied Sciences in biology, biotechnology, pharmaceutics, life sciences or in a closely related field.
• You have 3 to 5 years of professional experience in a similar position in an industry involved in the field of medical device, pharmaceutical or biotechnological diagnostics.
• You have strong knowledge of the standards ISO 13485 and 14971, as well as the 98/79/EC and FDA requirements.
• You are very familiar with MS Office (Excel, Visio, MS Project, etc.).
• Fluent in French and English (spoken and written), German an asset.
• Lean or six sigma certification will be an asset.