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Smiling employee in a conversation with a colleague in the office
ID: 108579

Supplier Quality Engineer

  • MedTech
  • Asap
  • Supplier Quality, Global Supplier Management
  • K-Recruiting GmbH
Contact:

Julius Strack

+49 89 1890998-614

julius.strack@k-recruiting.com

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

  • 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

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