Senior Consultant; Interim Management-, Integration- and M&A-Support, EHS

- Project Responsibilities:

• Perform a „Worst-Case-Audit“ incl. (Extract)
  • Review the ongoing Product- / Manufacturing Transfer activities against the requirements and regulations to ensure the full compliance (internal and external requirements) before and during first MDR-Audit and planned FDA-Inspection
  • Stress / challenge the employees behavior and their Audit-Management
  • Review Supplier-related Documentation (Changes, Non-Conformities, 8D-Reports, Risk-Files and Incoming Inspection documents)
  • Review Status of:
    • Quality- and Risk- Management,
    • Batch Records,
    • Complaint Handling, NC- /CAPA-Management, 
    • Preventive Maintenance and
    • EHS-Management
  • Checking all the relevant internal and supplier related documents against former Audit-Findings to ensure full compliance during the upcoming external audits

Project Responsibilities:
o Leading a team of 15 quality employees
o Responsibility for compliance with the specified quality standards
o Testing/control and consistent response in the event of non-
compliance with quality specifications
o Accompaniment or further development of the entire 
manufacturing process
o Ensuring and controlling compliance with occupational safety, 
GMP and multiple quality standards
o Continuous development of the Integrated Management System
in the area of quality at the site including change control 
management, validation / qualification, quality cycle and 
continuous improvement
o Management of internal audits including control of 5S program, 
cleanliness and order in the work area
o Responsibility for the processing of customer complaints

Senior Quality Engineering & Project Lead
Medical Devices: Global Corporate Integration Project
(Germany and Switzerland plus 5 Sites in France, Ireland and U.S.A.)

Project Coordinator:
- Integration of Corporate Quality System at 5 acquired Sites
- Create and Maintain Site-Based Quality Integration Plans
- Update the Legacy Quality System into EU-MDR- Ready Status o Aligned Remediation Approach with different Workstreams (Risk Management, Engineering, Manufacturing, R&D)
- KPI reporting and communication with M&A-Team and other
Stakeholder
- Integration / Remediation Support:
o Update of Risk Related Documents (RMF, RMR, FMEA ́s) against Global Corporate- and EU-MDR - requirements
o Update of the Inspection- and Control-Plans o Initiate Non-Conformance- / PMS- Activities:
 CAPA coordination (for internal and external findings) and ensure proper remediation
 Include NC/CAPA/Complaints/Scrap Rates/Trends into Remediations and Corrective Activities
o Support Updates of SOP ́s, WI ́s, etc.
o Provide guidance and training for implementation of robust
structures on the integrated and remediated activities

Senior Quality Engineering & Project Management Medical Device (Coated / Resorbable): M&A Integration Project (Israel) 

• Project Coordinator:
  • Confirm Due Diligence Results and asses the State of Compliance of the Quality System versus Internal (Corporate) and Regulatory Standards (ISO, FDA, etc.)
  • Close reporting to local Core Team Leads and global M&A-Leader 
  • Prepare Manufacturing Transfer from Israel to European Sites of the acquiring Corporation
• Project Support:
  • Audit existing procedures and documents to the standards and report non-conformances and findings (both current state and retrospectively):
    • Analyzing of Audit- and Inspection reports (Internal / External), NC/CAPA-Files, Complaints and Complaint Handling, Maintenance Reports, Monitoring Data, Trainings, etc.
    • Perform CAPA verification of effectiveness and add activities as necessary.
    • Batch record review 
  • Update the Manufacturing- and Quality System to meet the Corporate Standards
  • Update the Health and Safety System to meet local, international and Corporate Requirements
  • Update the Complaint Handling System to reduce the runtime and ensure a compliant communication to the involved authorities
  • Make recommendations to achieve compliance where shortfalls are found and identify improvement potentials, which increase the productivity and efficiency of manufacturing and facility and operational practices.
  • Training – Support:
    • FDA Preparation (1st time FDA-Audit in the Company)
    • Support during the FDA inspection
    • Thorough understanding of GMP and GCP (Good Clinical Practices) guidelines. 
    • Consultancy and guidance of all employees regarding Risk Assessment, Risk Analysis, Maintenance, NCR, CAPA, Complaint-Handling, etc
    • GCP, GVP, GMP, cGMP, GDP etc.
  • Planning, implementing, follow up projects of
    • Pest Control
    • Fatigue Testing
    • Preventive Maintenance

Interim Deputy of Site Quality Lead (during Site Closure) Medical Devices: Complete Site Decommissioning

(Austria)

 

• Project Coordinator:
  • Coordinate the Manufacturing Transfer during Site Closure with local (Austria), European (Switzerland, Germany) and Global (U.S.A.) Sites and Leaders
  • Coordinate the structured Archiving of all Manufacturing- and Quality related Documents and Records into a Swiss Archive
  • Tracking of Deadlines and Meeting with local and corporate Management
• Project Support:
  • Support ongoing Product- / Manufacturing Transfer activities to ensure the full compliance (internal and external requirements) until full closure
  • Taking over continuously more activities for continuously reducing internal employees:
    • Quality Management, 
    • Complaint Handling, 
    • CAPA-Management, 
    • EHS-Management and 
    • Doc. Control incl. Record Management and Archiving
  • Checking all the relevant internal and supplier related documents against former Audit-Findings to ensure full compliance during ongoing external audits until site-closure
  • • Prepare and Lead Quality related Meetings:
      • Monthly Management Reviews
      • Ongoing NC/CAPA- and Complaint-Status Meeting
    • Coordination and Support of ongoing Activities incl. newly found Complaints, Manufacturing Investigations and Corrective / Preventive Activities
    • Audit Preparation and Supporting Mock Audit
  • Support the controlled and structured Hand-Over of the Site at its last day