Quality Expert for Medical Device Software

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Quality Expert for Medical Device SoftwareDuration: 6 months with possible extensionLocation: Basel ResponsibilitiesManage 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 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.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, safety and security (quality manuals, regulatory cGMP guidelines, health authority requirements, international standards, SOPs, HSE, etc.). Promote and enforce compliance to guidelines.Support project management functions as a sub-team member in preparation for a Inspection.Write/contribute to internal compliance policy and/or comment to regulations.Ideal Background: Education: Graduate in a scientific field. Medical device software backgroundLanguages: English fluent in speaking / writing, German and/or French desirable. Experience:At least 3 years of relevant experience.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, 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 functionsAre you interested in a project in Switzerland? Kindly get in contact with me and send me your updated CV to m.becker(at)realstaffing.com or give me a call on +41 (0) 44 588 2669.Sthree Switzerland is acting as an Employment Business in relation to this vacancy.