Jobbeschreibung

Positionsnummer / Reference Number

CA2205025112019

Position / Job Title

QMS Consultant

Dauer / Project Length

3 Monate

Aufgaben / Tasks

• In depth conceptual as well as operational understanding of quality management systems for medical device companies
• Implement a new QMS, including authoring SOPs, defining process owners and stakeholders as well as approval processes
• Train a variety of employees with different roles and backgrounds regarding the usage and maintenance of the system
• QMS – setup in compliance with ISO 13485, MDR as well as NHS specific regulations for medical devices

Qualifikationen / Qualifications

• Multiple years of operational and strategic experience in the medical device industry in the fields of both Quality Assurance / Management as well as Regulatory Affairs
• Strong knowledge concerning the relevant regulatory norms (ISO 13485, MDR, NHS – policies) and the respective implications of BREXIT on the business operations within the UK
• Outstanding communication skills and knowledgeable in conceptualizing and holding trainings for a variety of stakeholders from different departments and with diverse perspectives on the business
• Fluency in English in both verbal and written form, German is a plus

Weitere Informationen / Further Information

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