Senior Quality Assurance Consultant-medical devices
Posted on Jun 28, 2021 by Michael Bailey Associates - Zurich
Senior Quality Expert for Medical Device Software 12 months contract Basel
We have an opportunity for experienced Quality Assurance Manager with prior expertise with supporting changes and upgrades to quality systems to be compatible with medical device software in accordance with requirements, ensuring 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, commercialized and maintained through its lifetime in compliance with medical device, software and data security regulations and standards.
* Write, review and approve deliverables (eg procedures, records, device documentation) and related tools (eg 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 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.
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 gguidance 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.
6Good organizational skills.
8. Ability to work in cross-functional teams including Quality, Technical Development, Regulatory, Human Factors, Risk Management, IT and other functions
The role is home based and in the future some presence in the office is required.
This is a Swiss based role with some flexibility to wrok from home
Michael Bailey International is acting as an Employment Business in relation to this vacancy.