Job Description

• Conducting and contributing to the management of the compliance review process, identifying and implementation of system improvements
• Writing of critical systems documents
• Internal Auditing
• 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 our Quality Management System
• Participate in R&D Projects to ensure projects comply with the companies' 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

Required Knowledge, Skills, and Abilities

The Candidate:

• A degree in electrical or mechanical engineering, or equivalent experience
• Experience of working with an ERP/MRP system for part master & parts list generation and maintenance
• A qualified ISO9001 auditor (ISO13485 preferable)
• Experience of working in a product design environment within a manufacturing company
• Experience of working in an ISO 9001 company with engineering change control, documentation control etc.
• Experience of regulatory work on electromechanical products
• Experience of Products with temperature or power control, (ideally refrigeration experience)
• Good communicator across all levels of the business
• Team Orientated