Project Lead - Software && Electromechanical

Job Description

32540

My client is a large consultancy firm based in Leeds, who are currently recruiting for a Project Lead for the Software & Electromechanical area within Healthcare. You will be advising clients on the appropriate usage of quality and regulatory standards relevant to the applications of software as medical devices such as
ISO 62304, ISO 62366, ISO 60601-1.

URGENT - Project Lead - Software & Electromechanical - REGULATORY

You MUST have the following experience:

Strong experience in Robotic Systems / Control Systems / Integrated Software/Embedded systems
as a Medical Device
Creation and/or maintenance elements of Quality Systems.
Strong and relevant experience in a quality role within a regulated industry.
Knowledge in Risk Management activities specific to the integration of systems and processes
Strong knowledge of FDA and MDD GMP requirements regarding medical Devices.
Knowledge and understanding of validation techniques such as validation planning, IQ/OQ/PQ,
change control and process verification.
Strong interpersonal skills.
Your responsibilites will be as follows:

Apply knowledge in Robotic/Control system and Integrated software/Embedded systems to drive
Medical Device Quality activities
Provide inputs to meet Design Control requirements and all applicable standards
Advise clients on the appropriate usage of quality and regulatory standards relevant to the
applications of software as medical devices such as ISO 62304, ISO 62366, ISO 60601-1
Work on documentation to integrate software and electro-mechanic systems and devices into an
existing portfolio of products.
Supporting risk assessment activities: Develop and utilise DFMEA/PFMEA and other QA risk analysis
techniques in order to minimise potential risk during development/implementation activity.
Review and provide input to Design Verification and Validation activities.
Supervise Process Validation, IQ, OQ, PQ as may be required to integrate electromechanical products
and systems.
Assist in managing the regulatory compliance program to include FDA and BSI.

Please send your CV to Glen.parker@lawesgroup.co.uk OR call 0203 375 9805




consultant

This job was posted by.

Sarah Brown

Tel: 0203 375 9805
Email: sarah.brown@lawesgroup.co.uk

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