• Lead and co-ordinate Risk Management activities involving interaction with various   
   departments.
• Lead the writing of the DFMEA for new product development
• Provide guidance to team on risk management, regulatory and quality engineering policies,  
    principles and best practices.
• Lead the upkeep/maintenance of Risk documents maintained within the quality management    
    system
• Ensure all risk management activities and documentation are compliant with all relevant Risk Management regulations.
• Lead the remediation of the noncompliance issues within the Risk Management Files and ensure documents are updated where required
• Train Employees to the Risk Management Process according to ISO 14971

• ISO 13485 Certification Audits
• GMP Audits
• CE- Conformity Assessment 
• Technical File Review                           

• Quality and Regulatory guidance for R&D projects
• Drive the team for the R&D documentation through the R&D phases
• Remediation of DHF files. Improve the product documentation of product portfolio
• GMP and Corporate Audits Support
• QMS optimization (Improvement of Product Development Procedure, Engineering Change Procedure, Risk Management procedure, Verification and Validation Guidance)
• Write Usability Engineering File according to IEC 62366
• Perform design reviews for R&D projects
• Deal with all R&D department CAPAs

• Quality Assurance Manager for the R&D project
• Drive the team for the R&D documentation through the R&D phases
• Lead the writing of the technical documentation for the project (Product Req Spec., SRS, HWRS, SWRS, etc.…)
• Work to have the strategy established to achieve the product CE-Marking and 510(K)
• Lead the review of the product technical documentation
• Write Risk Management documents (DFMEA, Risk Analysis, PFMEA, all risk reports)
• Write the quality documents for the project

• Project leader for Unique Device Identification/Direct Part Marking (DPM)
• Compose the project strategy plan and the project documentation
• Lead the review of the product technical documentation (product drawings, DHF, etc…)
• Update Risk Management documents
• Lead the change requests for implementing the DPM for the Navigation Products Portfolio
• Work with R&D, Manufacturing, Quality and Regulatory Affairs to review and approve the DPM documentation
• Update the DHF for the Navigation Products Portfolio
• Update Technical documentation for certificates

• Quality Project lead of Development project
• Writing of the regulatory requirements for the project
• Writing the supplier quality requirements contract for the new product (suppliers approval)
• Working with clinical team for establishing the clinical strategy for 510 (k) submission
• Driving the Team for completing the technical documentation
• Leading the R&D milestones tasks
• Create the project structure for the assigned scope, organize tasks and assign responsibilities to project team
• Analyse failures in DHF, develop with team appropriate solutions for non-conformities in DHF
• Write Regulatory documentation for Certification
• Update Technical documentation for certificates in Asia and Latin America
• Write & Perform Risk Management (DFMEA, User FMEA) for R&D project
• Solve CAPA and NCR on existing products

• Create the project structure for the assigned scope, organize tasks and assign responsibilities to project team
• Writing of the regulatory requirements for the project
• Analyse failures in DHF, develop with team appropriate solutions for non-conformities
• Design with concerned departments, resolution plans for failures found and implement them.
• Initiate and implement the solution through CAPAs

• Assess the Quality Management System regarding the Validation Process
• Improve the Quality Manual regarding the Validation Process
• Write the procedures (SOPs, work instructions and forms) for the Validation Process
• Assess the Risk Management Process and set Requirements for Improvement
• Train employees in new procedures

• Process Improvement (Risk Management; Calibration; Inspection, Test and Release; etc...)
• Writing SOPs and work instructions
• Updating Risk Management (DFMEA, PFMEA)
• Legacy Review (Interne auditing) of the production process and process validation
• Legacy Review (Interne auditing) of the calibration process
• Legacy Review (Interne auditing) of the supplier management process
• Legacy Review (Interne auditing) of the facility and cleanroom requirements
• Legacy Review (Interne auditing) of pest control and raw material requirements
• Writing the legacy review reports (audit reports) and the remediation plans (recommendation plans how to resolve the deviations and noncompliance found in the legacy review).

In Charge of:

• Implementation of R & D projects in production
• Provide technical assistance to the production teams for the entire project phase
• process optimization
• Production optimization and products developed in collaboration with R & D
• Write and Perform Risk Management (Risk Analysis, PFMEA)
• Qualification and validation of production facilities
• Training of production staff
• Audit preparation and presentation of production issues
• Production documentation control
• Computer System Validation

Projects:

Balloon Blow Process optimization

• Six sigma project (optimization of the balloon yield)

CAPA on pinhole issue

• Project Leader (team of 5 engineers)
• Initiation, investigation and implementation phases

CAPA on extrusion validation issue for tubing process

• Project Leader (team of 6 engineers)
• Initiation, investigation and implementation phases

Qualification of the extrusion equipment

• Project Leader (team of 2 engineers, 22 machineries):
• Equipment Installation qualification
• Equipment Operation Qualification

Validation of the extrusion tubing process

• Project Leader (team of 6 engineers)
• Developer of the Validation Strategy and the Validation Plan
• Writing of the process FMEA
• Participating in the performance of the risk analysis of the extrusion process
• Writing of the OQ and PQ plans
• Performance of the OQ and PQ runs
• Writing of the OQ, PQ and Extrusion reports

In Charge of:

• Document Management System Administration
• Update of the Document Management System Software
• Revision and Correction of Quality documents
• Conducting Internal Audits and supplier audits
• Supplier Qualification
• Writing SOPs
• Writing Work instructions
• Writing forms

Tasks:

• Documentation Control process
• Internal Audit Process
• Corrective and Preventive Action Process
• Quality Control Process
• Risk management process
• Validation process
• Suppliers Management process
• Change Management process
• Design control process

In Charge of:

• Research and Realisation of Development Projects

Projects

• Development of new stone-basket-tiples for the Urology*
• Development of new ureteral stents device
• Development of a new kind of dilatator for stones extraction
• Development of a new kind of coat for rigid ureter scopes**
• Development and construction of a Satinsky clamp
• Conception and Development of a vessel´s clamp for the Electro surgery (vessel welding with pressure and heat from the Current)
• Technical Documentation

Achievements

• Submission of two patents for new medical devices:
  • Patents on request