Project Quality Engineer
Type: Temp to Perm / Perm
Clinical Professionals is working with a global technology company that specialises in the development of medical devices.
Due to an increase in work demand, our client is currently seeking a Project Quality Engineer to support them with product development projects and implementation of new devices.
• Ensure compliance throughout each stage of the project development cycle.
• Write and review SOPs, specification and risk analysis documents
• Ensure conformance to regulatory requirements including as appropriate ISO 13485, ISO 14971 and 21 CFR part 820
• To guide the project team on all quality activities to achieve design control deliverables, product safety, risk management, compliance and product performance.
• Support the complete product development lifecycle
• Ensure development proceeds in accordance with QMS
• Review and approval of documents required to support medical device product development
• Degree or HND in engineering or life sciences field
• Excellent experience in new product development
• Quality Assurance/Quality Engineering related activities in medical devices
• Experience working with minimal supervision in a fast paced, multiple disciplinary environment
• Experience of the complete product development lifecycle
QMS, Quality Engineer, Medical Devices, Project, Project Management, product development, devices, ISO 13485, ISO 14971, 21 CFR part 820, Risk Analysis, SOP, Quality System, compliance, Risk Assessment, Validation, CAPA, Design
- Project Quality Engineer