We are searching for a Quality Assurance Expert for 12 months project to ensure technical development and manufacturing operations of assigned Medical Devices/Combination Products.
• Manage portfolio of assigned projects and provide a service functional expertise in area of responsibility for medical devices and combination products.
• Write, Review and approve deliverables (e.g. procedures, records, third party work, contractors, clinical trial material, components) and related tools (e.g. IT, document systems, training tools, facility validation) to ensure GMP compliance.
• Accountable for monitoring, analysis and reporting of GMP related KPIs as part of management reporting.
• Manage quality and technical matters and ensure they are resolved consistently and in accordance with global standards and policies.
• Release medical devices for clinical studies and commercial use.
• Support Medical Device Risk Management, through proactive risk management tools and approaches, • Represent the department in initiatives and cross-divisional projects.
• Lead project related activities (e.g. development of new tools, processes).
• Perform and support inspections and audits as required.
• Provide support to other line functions in GMP compliance related issues in area of Medical Device standards • Meet internal and external guidelines regarding quality and safety (quality manuals, regulatory cGMP guidelines, health authority requirements, SOPs, HSE, etc.)..
• Support project management functions in preparation for a Pre-Approval Inspection.
• Write/contribute to internal compliance policy and/or comment to regulations.
* University degree in a relevant subject
* Work experience in the pharmaceutical or medical device industry
* Experience in planning and writing technical documentation for Medical Devices and combination Products
* ISO 13485, ISO14971, MDD and QMS for Medical Devices
* Experience with Medical Device Design Control
* Ideally experience in the field of Auto-Injectors and Safety Devices
* Excellent communication skills in German and English
* Excellent Project Management skills
Please send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.