Beschreibung
9 month medical devices related remediation project based in Switzerland. Immediate start possible!Responsibilities:
- Handling, processing and documentation of packaging related CAPAs
- 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
- Verifying of packaging design compliance and packaging process validity according to ISO 11607
- Implementation of remediation actions to ensure compliance
- Partial preparation of Health Hazard Evaluation (HHE)
Requirements:
- Degree in Engineering (Packaging, Biomedical, Mechanical etc)
- Expert knowledge in ISO13485/ ISO11607/ ISOCRF820 are a must have
- Excellent experience in CAPA and complaint handling
- German and English fluent
If this role is of interest for you, do not hesitate to send your CV in Word including your hourly rate expectation for immediate consideration.