Description
Our client is international medical device company. Currently he is seeking for external support to strengthen his team. The position will be limited for a period of 6 months (good possibility of extension).Main Tasks:
- Performing and review of risk assessments (p-FMEAs and d-FMEAs) especially considering potential damage to the sterile barrier
- Checking for compliance with 21 CFR 820 and ISO 13485 (Design Control, Protocols, Hazard Identification, reports etc.)
- Execution, conduction and documentation of required investigations tasks for CAPAs
- Causal analysis for sterility related CAPA taking into account the checking of identification, traceability, manufacturing orders, supply chain, complaint screening
- Verifying of packaging design compliance and packaging process validity according to ISO 11607
- Implementation of remediation actions to ensure compliance
Your Profile:
- Experience with sterility / sterile production advantageous, or an equivalent combination of education and experience
- Interdepartmental communication and clarifications in order to drive the CAPA progress
- Pronounced quality perception and a thorough and reliable working style is a must
- Good communication, teamwork and organizational skills are essential
- IT knowledge e.g. MS Office is required
- Fluent German and English
You can expect a challenging and varied job in a multicultural environment. If this is something you are interested in please send your CV to Robert Galansky,