Manage portfolio of assigned projects, support a discipline and/or provide a service on his/her own or with a team of associates. Provide 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 to ensure GMP compliance
Ensure that new products including web-based and mobile applications have been effectively and efficiently verified and validated prior to their release and that these designs meet effectively documented and implied user needs and requirements.
Improve the overall quality of mobile software, including peer reviews, software hazard analysis, requirements traceability, defect tracking, software metrics, configuration management and software tool validations
Ensure that software quality assurance efforts are lifecycle oriented during product requirements development and continuing throughout its lifetime
Manage quality problems and technical matters and ensure they are resolved consistently and in accordance with global standards and policies
Release of medical devices for clinical studies and commercial use
Support Medical Device Risk Management, through proactive risk management tools and approaches, to minimize impact on global supplies and patients
Represent MD Quality in initiatives and cross-divisional projects
Lead project related activities in development of new tools and processes
Perform or support inspections and audits as required.
Provide support to BTDM line functions in GMP compliance related issues in area of expertise
Support a culture of high performance and trust. Assure that the required level of knowledge and skills is available and identify competency gaps. Establish and implement training and development plans.
Meet internal and external guidelines regarding quality and safety
Support project management functions as a sub-team member in preparation for a Pre-Approval Inspection.
Contribute to internal compliance policy
Quality Specialist for Medical Devices
Degree in a scientific field. Medical device software background is a plus.
English fluent in speaking and writing, German and/or French desirable.
At least 3 years of industry experience.
Practical experience in IEC 62304, IEC 82304, ISO 14971, MDD/MDR, GDPR, 21 CFR part 820 / part 4 requirements and in Medical Mobile Applications
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