Your tasks:

• Review and technical evaluation of incoming amendment requests
• Planning all measures required for implementing changes within the change control process.
• Ensuring complete and traceable documentation of changes
• Active participation in the further development and optimization of the change control process.
• Planning, preparation and execution of internal audits and supplier audits
• Coordination and support of external audits, e.g. by customers or notified bodies
• Controlling the processing of audit deviations
• Providing data and KPIs for quality management reviews and trend analyses

Your profile:

• Completed scientific training or successfully completed studies in natural sciences or economics.
• Several years of professional experience in quality management, ideally in the regulated environment of the medical device, cosmetics or pharmaceutical industry
• Sound knowledge of relevant normative and regulatory requirements, in particular ISO 9001, ISO 13485, GMP, MDR and/or AMG
• Experience in change control and audit management, as well as in conducting and coordinating risk and quality assessments.
• Good German and English skills, both spoken and written.
• Structured, meticulous and independent work style as well as strong communication and coordination skills

Your tasks:

• Review and technical evaluation of incoming amendment requests
• Planning all measures required for implementing changes within the change control process.
• Ensuring complete and traceable documentation of changes
• Active participation in the further development and optimization of the change control process.
• Planning, preparation and execution of internal audits and supplier audits
• Coordination and support of external audits, e.g. by customers or notified bodies
• Controlling the processing of audit deviations
• Providing data and KPIs for quality management reviews and trend analyses

Your profile:

• Completed scientific training or successfully completed studies in natural sciences or economics.
• Several years of professional experience in quality management, ideally in the regulated environment of the medical device, cosmetics or pharmaceutical industry
• Sound knowledge of relevant normative and regulatory requirements, in particular ISO 9001, ISO 13485, GMP, MDR and/or AMG
• Experience in change control and audit management, as well as in conducting and coordinating risk and quality assessments.
• Good German and English skills, both spoken and written.
• Structured, meticulous and independent work style as well as strong communication and coordination skills