Quality Management Specialist
vor 14 Stunden
Location: Berlin, Germany (Remote/On-site as needed)
Job Type: Freelance/Contract
Contact Length: 4/6 months (Potential extension)
Position Overview:As a Freelance QMS Consultant, you will play a crucial role in ensuring that our quality management system complies with ISO 9001 standards and meets the requirements of the MDR. You will work closely with our internal teams to oversee document control, traceability, and the implementation of Unique Device Identification (UDI) systems. Additionally, you will ensure that our products are prepared for CE Marking, facilitating market access across the European Union.
Key Responsibilities:- QMS Compliance: Ensure that the company's quality management system adheres to ISO 9001 and MDR requirements, providing expert guidance on best practices and continuous improvement.
- Documentation Control: Develop, review, and maintain quality documentation, ensuring compliance with regulatory requirements and internal standards.
- UDI Implementation: Support the implementation and maintenance of Unique Device Identifier (UDI) systems to ensure accurate product identification and traceability.
- CE Marking: Assist in preparing and maintaining documentation necessary for CE Marking of medical devices, ensuring compliance with EU regulations.
- Traceability Management: Oversee the traceability of materials, components, and products throughout the production process to ensure compliance with regulatory requirements.
- Training & Support: Provide training and support to internal teams on QMS processes, regulatory requirements, and documentation control.
- Audit Preparation: Assist in preparing for internal and external audits, ensuring all quality system documentation and processes are audit-ready.
- Language Skills: Fluency in both German and English.
- Experience:
- Extensive experience working with ISO 9001 in the context of medical devices.
- Strong understanding of the European Medical Device Regulation (MDR).
- Proven experience with UDI systems, traceability processes, and CE Marking.
- Technical Skills: Proficiency in document control systems and quality management software.
- Soft Skills: Strong analytical, organizational, and communication skills with the ability to work independently and manage multiple tasks.
- Duration: 4 months until the end of the year with the possibility of extension based on project needs.
- Compensation: Competitive hourly/daily rate, commensurate with experience.
- Location: Berlin-based, with flexibility for remote work and on-site presence as required.
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