Beschreibung
Freelance - Materials Control Expert - SwitzerlandMy client is an international Top 10 medical devices company with approximately 12.000 employees and net earnings of US$ 908 million back in 2010. The company is known for its implants and biomaterials used in correction and regeneration of human skeleton as well as surgical fixation is currently seeking for a Material Control Expert in Switzerland.
Duties and Responsibilities:
* With oversight from the Core Team Leads, determine and report on the state of compliance of the quality system versus regulatory standards for Medical Device Instustry (ISO, FDA, etc.).
* Audit sites' procedures 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.
* Perform CAPA verification of effectiveness as necessary.
* Be willing and able to travel to other sites in Europe (Switzerland, Germany, Austria) as required. * Thorough understanding of GMP and GCP (Good Clinical Practices) guidelines
Experience:
* Minimum of 4 years quality / compliance experience in the medical device or pharmaceutical industries.
* Prior experience in medical device / pharmaceutical remediation preferred.
* Familiarity and interaction experience with regulatory auditing bodies preferred.
* Documented training in FDA QSR, ISO required.
* Proficient in the use of Microsoft Office, MS Visio and / or MS Project are a plus
* Some ERP Knowledge (preferably Agile, JD Edwards and SAP)
This is a phenomenal chance for you to participate in one of the biggest and most interesting projects inSwitzerland. If you are looking for a challenging and varied freelance role in a global Medical Devices environment, a market-based compensation package and modern working conditions, you should apply immediately.
For more information about this role or jobs within related specialist areas please send me your CV with your hourly rate expectation for immediate consideration. You can reach me on or m.muller'at'realstaffing.com
Keywords: materials, material controls, medical device, ISO, 13485, 9001, FDA, FDA QSR, Audit, CAPA, GMP, GCP, English AND German, freelance, Switzerland
To find out more about Real please visit www.realstaffing.com