Generalist with strong experience in many different areas including Supplier Quality Management, Regulatory Affairs/MDR and Manufacturing Transfers
Not only is experienced in Supplier Management regionally but also globally through projects at Big Medical Devices Companies
Has worked mainly in medical devices industry and therefore is fully aware about the industry standards and regulations
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Our content and services may vary by location.
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Overview
- Availability
- Asap, full-time, onsite & remote
- Qualification
- Diploma Technical Business Administration
- Language Skills
- German (native), English (business fluent)
- Relevant Expertise
- Supplier Quality, Global Supplier Management, Supplier Selection, Supplier Qualification, Supplier Transfer, Risk Management, Stakeholder Management, MDR, GXP, ISO 13485, Medical Devices
Key-Facts
Extract from previous activities
Medical Devices Company, Germany
Supplier Quality Engineer
Responsible for Advanced Supplier Quality Engineering in the area of purchasing in the EMEA region
Establishment of a regional SQ network
Development of SQ competencies through training and consulting
Leading the team to ensure APQP processes are in place at suppliers
Prioritization, assignment of tasks and balancing of SQ resources according to project requirements
Implementation of purchasing procedures as well as evaluation of proposed changes to procedures and metrics
Big Medical Devices Company, Germany
Consultant Global Supplier Management
Supplier Assessment, -Qualification & -Management
Issue Management (discrepancies)
Vendor initiated Change-Management
Communication and coordination with multiple stakeholders and divisions within the global organization
Top5 Medical Devices Company, Germany
RA - EU MDR Consultant
Ensuring compliance during implementation the new EU MDR
Conduct DHF/DMR gap assessments
Regulatory documents - creation, update, review
Technical Files / General Safety Performance
Requirements / Lists of Applied Standards
Supporting product- and document changes
Project coordination: Performance of meetings and
Workshops, update EU MDR scope-lists and -charts, creation, and update of “Software-/ Product-Compatibility Matrix”
Top5 Medical Devices Company, Germany
Consultant Manufacturing Transfer & SQM
New product implementation & supplier coordination (Medical Devices)
Supplier Quality Management: Supporting vendor qualification, Conducted “Deviation Management / CAPA”, Managing of product- and document-change-requests
Supporting in “Design Control“: Creation of „Purchased Part Specifications“, Review various types of DHF-/DMR-documents incl. risk management files and verification-/validation documents, Supporting the creation of “Biocomp Assessment Files”, Collection and maintenance of “Material Master Data”
Medical Devices Company, Germany
Consultant Manufacturing Transfer
Medical Devices – Dislocation of raw materials and component parts
Cooperation in “Quality Assurance”
Creation and review various types GxP-documents
Assistance in “Design Control” (document reviews)
Supplier transfer- and qualification plans
Validation documents “DQ to PQ”
Risk management tables
Supplier Quality Management
Deviation Management / CAPA
Change Management