Beschreibung
Suche DRINGEND asap FL für den Packaching Bereich für ein Medizintechnikunternehmen in Tuttlingen für 6 Monate.Das kommt auf Sie zu:
- to meet design requirements for the packaging of medical devices (implants and instruments)
- according and in compliance to ISO , 21CFR, ISO 13485
- guidelines like specific GSOPs and SOPs
- design control requirements shall be ensured, verified, achieved and properly documented
- revision of supporting documents like packaging related DCTMs, DFMEAs, Change Logs, packaging specifications, purchase specifications, packaging instructions, packaging design verifications, DOEs, packaging (sealing) validations, packaging stability testing
- project management of required tests to demonstrate compliance
- experience in the medical device industry
- Strong communication, teamwork and organizational skills are essentially.
General Functions
- Design Control, Design History Files (DHFs
- determination of packaging gaps, regarding compliance according to ISO , ISO , 21 CFR and ISO 13485 (design control, hazard identification, process validation, protocols, reports etc.)
- Project Management
- risk assessment in the context of packaging related CAPAs, Complaints, internal and Suppliers Audit reports
- IT knowledge e.g. MS Office is a must
Was halten Sie davon?
Würde mich freuen von Ihnen zu hören, oder wenn Sie nicht interessiert sind, kennen Sie jemanden der das übernehmen würde, wenn ja, freue ich mich!