Medical Device Software Quality Expert
Posted on Jun 29, 2021 by RM IT Professional Resources AG
Senior Quality Expert/Compliance Lead vacancy for a globally operating Basel based company in the pharmaceutical sector.
- Academic degree in a scientific field paired with medical device software background
- At least 3 years of relevant 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
- Excellent knowledge of cGMP, medical device software regulations, standards and guidelines as well as well-versed with medical device software development and life cycle management
- Sound scientific, technical and regulatory knowledge in a specific area combined with outstanding analysis and evaluation of GMP compliance
- Outstanding organizational skills paired with ability to work in cross-functional teams including Quality, Technical Development, Regulatory, Human Factors, Risk Management, IT and other functions
- Languages: English, fluent in written and spoken, German or French are advantageous
- Providing QA functional expertise in the review of QMS processes for compliance to regulations, standards and guidelines related to Medical Device Software
- Managing portfolio of assigned projects, supporting a discipline and assuring functional expertise in area of responsibility for medical device software
- Ensuring the development and commercialization of new medical device software products including web-based and mobile applications as well as their maintenance through its lifetime in compliance with medical device, software and data security regulations and standards
- Meeting internal and external guidelines regarding quality, safety and security lines such as quality manuals, regulatory cGMP guidelines, health authority requirements, international standards, SOPs and HSE
- Improving the overall quality of medical device software, tools and procedures, including peer reviews as well as administrating quality problems and technical matters and ensure they are resolved consistently and in accordance with global standards and policies
Location: Basel, Switzerland
Does this Spark your interest? Then take the next step by sending us your CV as a Word document and a contact telephone number on which you are reachable during working hours.
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As a preferred recruitment agency for Swiss banks, international insurances, finance service providers, software and pharma companies, we acquire exciting positions since 1998 in Zurich, Bern, Basel and other regions in Switzerland every day.
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