QA Expert, Medical Device Software
An exciting vacancy has arisen for a Quality Expert, working Medical Device Software, you will be expected to support the review and maintenance of processes of the Quality Management System. The Swiss based role will expect you ensure high product quality, regulatory compliance and operational efficiency.
- 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.
- Support project management functions as a sub-team member in preparation for Inspection.
- Write/contribute to internal compliance policy and/or comment to regulations.
Skills and Requirements
- 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, 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, working knowledge of medical device software regulations, standards and guidelines.
- Good knowledge of medical device software development and life-cycle management.
- Good organisational 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
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.