Senior Quality Engineer



Our client a medical device multinational who are developing an innovative device are looking for an experienced Senior Quality Engineer to join their team. Reporting to UK based Quality Manager the Senior Quality Engineer will be required to provide Quality Engineering support for manufactured or subcontract manufactured current and development products. This is a great opportunity for someone looking to make a step in their career





Role/Responsibilities

• Review and/or generation of non-conformance reports, CAPA, audit, validation protocols/reports, risk management, supplier/vendor management and design change documentation.

• Provide Quality Engineering support for activities including nonconformities, CAPA, validation and risk management activities
• Deputise for the Quality Manager as and when required
• Support product design change activities
• Act as the Local Quality Representative (LQR) for Ireland site
• Validation support

• Life science, engineering, medically related degree or appropriate experience
• Detailed knowledge of ISO13485, ISO 14971 and 21CFR Part 820 Quality System Regulation (QSR)
• 4-6 years’ experience in a medical device Quality Engineering role
• Experience in nonconforming product management, CAPA, design change activities and validation activities
• Excellent communication skills

• Knowledge of Quality tools and statistics
• Experience in neurological or drug delivery devices
• Additional validation experience (process, equipment, cleaning, sterilisation, Test Method Validation)
• NPI
• Knowledge of injection and extrusion moulding processes
• Lead auditor trained
• 6 sigma green belt or above