Archiviertes Projekt - Quality Expert for Medical Device Software
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* Manage portfolio of projects by providing functional expertise for medical device software.
* Ensure that new medical device software products including web-based and mobile applications are developed, commercialized and maintained through its lifetime in compliance with medical device, software and data security regulations and standards.
* Write, review and approve deliverables (e.g. procedures, records, device documentation) and related tools (e.g. IT, document systems, training tools) to ensure compliance to medical device and software regulations and standards.
* Improve the overall quality of medical device software, tools and procedures, including peer reviews.
* Manage quality problems and technical matters and ensure they are resolved consistently and in accordance with global standards and policies.
* Represent MD Quality in initiatives and cross-divisional projects.
* Support inspections and audits as required.
* Meet internal and external guidelines regarding quality, safety and security (quality manuals, regulatory cGMP guidelines, health authority requirements, international standards, SOPs, HSE, etc.). Promote and enforce compliance to guidelines. .
* Practical experience in managing projects in compliance with ISO 13485, 21 CFR part 820 / part 4, IEC 62304, IEC 82304, ISO 14971, IEC 62366, MDD/MDR, IEC 62304, IEC 82304, GDPR and other relevant standards and guidances related to medical device software.
Ability to influence people, negotiate and communicate.
* Sound scientific, technical and regulatory knowledge in a specific area.
* Excellent knowledge of cGMP, working knowledge of medical device software regulations, standards and guidelines.
* Good knowledge of medical device software development and life-cycle management.
* Good organizational skills.
* Good and proven ability to analyze and evaluate GMP compliance.
* Ability to work in cross-functional teams including Quality, Technical Development , Regulatory, Human Factors, Risk Management, IT and other functions
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