Aspire is in partnership with a group of companies that specialized in the design, manufacture, and distribution high-performance wound care products and surgical solutions.
Quality Systems Manager
Germany, Nuremberg
This world-leading independent developer and manufacturer company is looking to hire a Quality Systems Manager.
Responsibilities:
- Ensure the quality management system meets the local and international legal requirements (ISA 13485:2016, MDD, MDR, cGMP-USA).
- Organizing and leading the quality systems team.
- Act as a representative of the site management.
- Responsible for the management of the QM system including the implementation of the forthcoming new European Medical Devices Regulation
- Supporting key project teams.
- Support development on quality issues so that new products are designed and developed in accordance with design control and validation requirements.
- Conducting and supporting internal, group and external audits and inspections, ensuring timely and appropriate responses.
- Responsible for the management of the QM system including the implementation of the forthcoming new European Medical Devices Regulation
Requirements:
- 2-5 years experience of Quality Management or Regulatory Affairs
- Medical Devices Industry
- Understanding of applicable quality system regulations and ISO quality requirements is necessary.
- Ability to plan and/or monitor quality systems/processes, documents and supplier audits/assessments.
- Very good knowledge of German and English language.