Beschreibung
Real is currently working with one of the world's leading medical devices company on an exciting project to support their global quality and regulatory strategy and is looking for the industry's top QA and Regulatory Affairs specialists to fill a number of contract positions based across Switzerland.Equip & Facility Engineer - Manufacturing
I am currently seeking an Equip & Facility Engineer for a 5 month project in Switzerland.
Requirements:
My client is looking for an Engineer with compliance experience in the Medical Devices environment. You should be familiar with documented trainings in FDA QSR, ISO 13485 and ISO 9001. A thorough understanding of GMP and GCP guidelines are necessary. Ideally you are also familiar and have interaction experience with regulatory auditing bodies.
Duties and Responsibilities:
- Audit sites' inspection Plan to the standards and report out on findings (both current state and retrospectively).
- Make recommendations to achieve compliance where shortfalls are found.
- Provide Audit reports as directed.
- Consultancy and guidance of all employees and manager regarding manufacturing and facility and operational practices.
- Training of all involved employees along the manufacturing and facility process.
- Consultancy and guidance of all employees regarding PFMEA and Risk Management
- Bringing in of improvement proposals, which increase the productivity and efficiency of manufacturing and facility and operational practices.
- Consultancy and guidance of all employees regarding maintenance
Language: German and English
Contact:
I am specialized in the pharmaceutical and medical devices market and am currently taking care of more than 20 freelance projects within the Medical Devices area inSwitzerland. If you're a QA or Regulatory Affairs specialist looking for your next challenge and the opportunity to work in one of Europe's top 10 places to live I would like to hear from you.
For more information about this role or other projects please send me your CV with your hourly rate for immediate consideration. You can reach me on or m.muller'at'realstaffing.com
Keywords: Equip & Facility, Engineer, Manufacturing, ISO, FDA, Audits, PFMEA, Risk Management, GMP, GCP, ISO 13485, ISO 9001, German, English,Switzerland, Freelance
Campaign Ref: CH
To find out more about Real please visit www.realstaffing.com