Beschreibung
We are recruiting for experienced QA manager with previous experience in Medical devices software to support and lead specific initiatives in SaMD (Software and medical device) and in MDSAP certification (Medical Device Single Audit Program).Major Accountabilities:
Active support and drive in the global TRD project organisation working on the QMS adaptation for SaMD and MDSAP.
Lead and drive assigned initiatives within the project. Ensure quality oversight with strong quality guidance, scientific and technical expertise.
Contribute to the strategy of assigned projects incl. contingency planning and risk assessments as appropriate to ensure timely achievement of project quality deliverables. Ensure that the strategy followed within the assigned projects is in line with overall strategies and goals and in compliance to cGMP guidelines and internal procedures.
Understand and proactively manage the interactions between the project organisation and the key involved functions and stakeholders.
Provide expertise and support on SaMD and MDSAP to the project organisation and provide direct support to the relevant project workstreams
Active support to the project leads to proactively communicate overall project strategy, key issues and any other critical topics in a timely manner to the appropriate management level/ steering committee.
Lead the preparation for the MDSAP certification, with a focus on the QMS adaptation and readiness for inspection.
Requirements:
Education: degree in a scientific field: Medical device software background. Experience with MDSAP
Practical experience in managing projects in compliance with ISO 13485, 21 CFR part 820 / part 4, MDSAP, IEC 62304, IEC 82304, ISO 14971, IEC 62366, MDD/MDR, GDPR and other relevant standards and guidelines 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.
Ability to work in cross-functional teams including Quality, Technical Development , Regulatory, Human Factors, Risk Management, IT and other functions
Michael Bailey International is acting as an Employment Business in relation to this vacancy.