An opportunity for a Quality Systems and Regulatory Engineer to join an international market leader in the manufacture of laboratory equipment for the science and research sectors.
Key responsibilities of the role will include:
Conducting and contributing to the management of the compliance review process, identifying and implementating of system improvements.
Writing of critical systems documents.
Risk Assessment and Management.
Training and assessing company employees in relation to the QMS and regulatory requirements.
Ensure the company is informed and has up-to-date information on all applicable and necessary specifications and standards.
Ensure conformance to regulatory requirements.
Provide support and direction on all quality activities necessary for the project team to achieve design control deliverables, specifically deliverables related to product safety,usability, device risk management, compliance and product performance
Facilitate FMEA, Control Plans, Hazard Analysis, Critical Design Review on behalf of the project team.
Support the Quality Assurance Manager in deploying new, or changes to, existing processes and systems to improve the overall effectiveness, efficiency and compliance of QualityManagement Systems.
Participate in R&D Projects to ensure projects comply with the company’s Quality Management System, and that the resulting products comply with relevant safety, regulatory and other product standards.
Carry out systematic data analysis of non-conformances and create presentations to deliver results to relevant departments.
Ideally Qualified in an Electrical or Mechanical Engineering discipline (or equivalent), you should be a Qualified ISO 9001 auditor or, better still, an ISO 13485 auditor. You should be experienced in a product design environment within a manufacturing business, one that runs an ERP system, and ideally one where you have gained experience of regulatory work on electromechanical products. Experience of products with temperature or power controls would be particularly relevant.
Additionally the Quality Systems and Regulatory Engineer needs to be a team player with excellent communication skills.
- Quality Assurance
- Quality Control
- Regulatory Requirements
- Regulatory Standards
- ISO 9001
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