Project Quality Engineer
We have a new vacancy for an experienced Project Quality Engineer to join a highly respected Technology Consultancy specialising in Engineering, Product Design and external R&D services. You will be working as an integral member of a cross functional team to assist delivery of medical product development projects.
Ensure conformance to regulatory requirements including as appropriate ISO 13485, ISO 14971, ISO 62304 ISO 62366 and 21 CFR part 820.
Provide support and direction on all quality activities necessary for the project team.
Ensure development proceeds in accordance with Quality Management System.
Escalate issues and risks pro-actively through appropriate channels.
Actively participate in and/or facilitate the development, review, and approval of Quality Plans, Risk Management Plans, Verification Plans and Design Review Plans, requirements, traceability, architecture, verification/validation etc.
Facilitate FMEA, Hazard Analysis, Critical Design Review on behalf of the project team.
Act as the main point of contact for clients’ QA teams.
Attend critical design reviews and face-to-face client meetings; some international travel may be required.
Degree or HND in engineering or technical discipline
Proven experience in new product development and quality engineering related activities in a medical device environment.
Proven track record of conformance to regulatory requirements including as appropriate ISO 13485, ISO 14971, ISO 62304, ISO 62366 and 21 CFR part 820.
Flexibility to operate within various client organization Quality Management Systems.
Experience working with minimal supervision in a fast paced environment.
Experience of the complete product development lifecycle.
Knowledge and use of a variety of risk management tools, design and process control activities, verification and validation testing methodologies to support product quality for new and existing product development.
Good written and communication skills