Quality Expert for Medical Device Software

Beschreibung

Quality Expert for Medical Device Software

Duration: 6 months with possible extension

Location: Basel

Responsibilities

• 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 (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 background

• Languages: 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 functions

Are you interested in a project in Switzerland? Kindly get in contact with me and send me your updated CV to or give me a call on .

Sthree Switzerland is acting as an Employment Business in relation to this vacancy.