Knowledge in production and process validation for active and non-active medical devices (class I (Is), IIa & IIb, class III), including implants
Strong knowledge in designing risk analysis and risk management documentation for technology driven medical products
Certified 1st and 2nd party Auditor (Internal Audits & Supplier Audits) ISO 9001 / ISO 13485 & 21CFR820
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Our content and services may vary by location.
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Overview
- Availability
- Asap, 5 days/week, on-site & remote
- Qualification
- Diploma Electrical Engineering
- Language Skills
- German (native), English (business fluent)
- Relevant Expertise
- Quality Engineering, Risk Management, MDR, Sterility Assurance, PRRC, KPI Management, Mock-up Audits, Quality Management, Medical Devices
Key-Facts
Extract from previous activities
Medical Devices Company, Germany
Quality Management
Management of the direct reports of the Quality Engineering department
Teamlead Quality in Operation and Release
Personnel resources and budget responsibility for the department cost center
Leading and monitoring of KPIs in Quality Engineering
Remediation of legacy Supplier Quality
Internal and Supplier Audits
KPI Management
Medical Devices Company, Germany
Intermin QM Manager
Act as Interim Head of Quality Management
Quality Engineering
Remediation of legacy CAPA’s and Supplier Quality
NC, CAPA and Supplier Quality Transition and general process transitions
Internal and Supplier Audits
Sterility Assurance
MDR readiness
CSV Process design and execution
Medical Devices Company, Germany
CAPA-Manager
CAPA Coordination to ensure traceable content, quality and timeliness
Computerized Systems audits
Remediation of legacy CAPA’s and Supplier Quality for FDA Readiness
FDA Inspection due PMA program
MDSAP Audit
CAPA and Supplier Quality Transition
KPI Management
Medical Devices Company, Germany
CAPA Manager
CAPA Coordination to ensure delivery in content, quality and time
Lead and drive CRB's and Support CAPA Owner / CAPA Project Teams
Response Letters to Competent Authorities of Audits & Inspections
KPI Management
Medical Devices Company, Germany
Quality Auditor
Conduction of internal audits according 21 CFR 820; ISO EN 13485:2012; MDD; TGA, RDC 59 (ANVISA), Ordonnance 169 (J-PAL) regulations
Writing of internal and reports and creation of relevant documentation
Follow up of internal and external audit observation to assure appropriate and timely implementation of Corrective Actions
Provide Regulatory Compliance support in all areas of Quality System Elements
Documentation review in Quality System relevant areas
Quality Engineering
Medical Devices Company, Switzerland
Quality Engineering
Breakdown & implement global procedures to site specific SOP & WI, based on audit observations by complaints
Supplier Quality Engineer for new built SQA themes
Act as 1st party process lead auditor to ensure compliance to internal SOP & WI as well to Corporate and company processes and quality directive
Act as 2nd party auditor (Supplier Auditor) to Supplier
Medical Devices Company, Switzerland
Supplier Validation Engineer
Technical expert for the validation processes at suppliers
Responsibility to ensure compliance for company and its suppliers
Resolve & manage technical operational problems in area of expertise for the supplier
Project planning & execution for process validation remediation actions for all suppliers
Review and approve of validation master plans, protocols, summary reports and other documentation associated with validations from suppliers
Execute qualification & process validation reviews according the requirements
Execute audits according ISO 13485 and 21CFR820