27.09.2017 aktualisiert
100 % verfügbar
Medical Device VP Operations, COO, consultant, contractor
Lugano, Schweiz
Schweiz
Industrial Diploma, mechanical EngineeringSkills
VerfahrenstechnikLeanFertigungFDACOOtechnologyMedical DeviceISO 13485ChinaOperationscatheterCFDANPITransferscale upGMPCAPAERPAuditBeratungInstandhaltungProcurementReinraumProduktionsbetriebManagementProduktioninternationalSupply ChainDue DiligenceStrategiePlanungcontinous improvement
- Working Knowledge of: UNI EN ISO 9001, ISO 13485, FDA 21 CFR PART 820V, MDDV, 510KV, GMP, GLP, GDP, GCP, Chinese CFDA, YY0033, ISO10993-7:2008, OSHA, ISO 8601, EN1041, EN11607, ISO 10012.
- Outstanding know how of Catheter and combo product manufacturing: PAD, PTA, PTCA, EPS, CPS, STENT, DEB.
- On the Field matured experience in Plastic Material Transformation technologies (compounding, micro-extrusion, injection and blow molding)
- Proven capabilities in building and kicking off production plants, speeding up NPI, rapidly scaling up production volumes, effectively transfer production lines, restructuring, business conversion revenue recovery
- Extensive track record of Lean Manufacturing, TPM and OEE projects for equipment and plants.
- Subject Matter Expert Process (SME) for Process Validation according to ISO 13485, FDA and CFDA.
- FDA and CFDA audits.
- Deep knowledge of Strategic Sourcing and Supplier management.
- Strong track records of Product lifecycle Cost Management initiatives
- Business acumen since product Industrialization, make or buy strategy and technology road map
Sprachen
EnglischverhandlungssicherItalienischMuttersprache