Beschreibung
One of the largest healthcare organisations in the world is currently in need of a Medical Device Quality Expert to step in for a fixed term temporary assignment in Austria. This is a fantastic opportunity for a seasoned Medical Device/Combination Products professional to impact the technical development and quality practices in a highly innovative environment.The Role:
- Manage portfolio of assigned projects, providing functional expertise in area of medical device and combination products
- Write, review, and approve deliverable and related tools to ensure GMP compliance
- Monitory, analysis, and reporting of GMP related KPIs
- Manage Quality problems and technical matters ensuring they are resolved consistently and in accordance with global standards and policies
- Medical Device Risk Management
- Perform or support inspections and audits as required
- Coaching and development, establishing and implementing training and development plans
Your Profile:
- At least 3 years of relevant experience
- Fluent English in both written and spoken form
- Degree in Chemistry, Pharmacy, Microbiology, Biotechnology, or related sciences
- Excellent knowledge of cGMP, working knowledge of medical device and combination product regulations
- Good knowledge of medical device development and lifecycle management
- Strong regulatory, technical, and scientific knowledge in a specific area
Desired Skills:
- German and/or French Skills
Should you match the above requirements, please submit and updated version of your CV and we will be in contact shortly.
Key Words: GMP, GxP, Medical Device, Med Dev, Combination Products, cGMP, Risk Management, Quality, SOP, Regulatory, Regulatory CGMP, ISO 13485, English, French, German
Mehr Informationen über Real Staffing erhalten Sie unter www.realstaffing.com/de