03.04.2025 aktualisiert
Premiumkunde
100 % verfügbarQA/RA Product & Project Manager Expert in Medical Device
Delemont, Schweiz
Skills
PaketierungChange ControlTechnische DokumentationAuditierungR&DQualifizierungCAPARisikomanagementDokumentationFMEAProduktkontrolleProzessoptimierungprocess validationKünstliche IntelligenzNotify Body Auditor
- Notify Body Auditor
- Proficient in Quality Systems as ISO-13485 and ISO-9001, ISO 19011, DIN EN ISO 14971, 21CFR Part 820, 21CFR Part 11, GAMP5, IEC 62304
- Proficient with:
- Quality Assurance
- Quality management requirements
- Quality control
- Technical documentation
- FDA 510(K) Submission preparation
- product development
- project management
- Process optimization
- FMEA
- risk management
- Change control
- auditing
- qualification
- CAPA system
- Medical Device Regulations
- Clean room requirements
- packaging
- Process validation
Sprachen
DeutschverhandlungssicherEnglischverhandlungssicherFranzösischMuttersprache
Projekthistorie
- Manage a portfolio of assigned projects and provide functional expertise in area of responsibility for medical devices and combination products
- Provide Quality and Regulatory guidance in development projects of combination devices
- Write, review and approve deliverables (e.g. procedures, records, third party work, clinical trial material, components) to ensure GMP compliance
- Support Medical Device Risk Management, through proactive risk management tools and approaches, to minimize the impact on global supplies and patients - Release of medical devices for clinical studies and commercial use
- Perform inspections and audits
- Provide Quality and Regulatory guidance in development projects of combination devices
- Write, review and approve deliverables (e.g. procedures, records, third party work, clinical trial material, components) to ensure GMP compliance
- Support Medical Device Risk Management, through proactive risk management tools and approaches, to minimize the impact on global supplies and patients - Release of medical devices for clinical studies and commercial use
- Perform inspections and audits
Field of action as an auditor:
- ISO 13485 Certification Audits GMP Audits CE
- Conformity Assessment (MDR /MDD Audits)
-Technical File Review
- ISO 13485 Certification Audits GMP Audits CE
- Conformity Assessment (MDR /MDD Audits)
-Technical File Review
Field of action as an auditor:
-ISO 13485 Certification Audits
-MDSAP Audits CE
- Conformity Assessment (MDR /MDD Audits) GMP Audits
-Technical File Review
-ISO 13485 Certification Audits
-MDSAP Audits CE
- Conformity Assessment (MDR /MDD Audits) GMP Audits
-Technical File Review