Quality Expert for Medical Device Software
Proclinical are in search of a Quality Expert in Medical Device Software based in Switzerland. You will be expected to support the review and maintenance of assigned processes. You will also support the development and commercialisation of assigned Medical Device Software Projects.
- Provide QA functional expertise in the review of QMS processes for compliance to regulations, standards and guidelines related to Medical Device Software.
- 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 device software.
- Ensure that new medical device software products including web-based and mobile applications are developed, commercialised 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.)
- Support project management functions as a sub-team member in preparation for an inspection.
- Write/contribute to internal compliance policy and/or comment to regulations.
Skills and Requirements
- Graduate in a scientific field. Medical device software background.
- English fluent in speaking / writing, German and/or French desirable.
- At least 3 years of relevant experience.
- Practical experience in managing projects in compliance with ISO 13485 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.
- Ability to work in cross-functional teams including Quality, Technical Development , Regulatory, Human Factors, Risk Management, IT and other functions
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.