Senior Quality Engineer

Stryker seeks a Senior Quality Engineer to establish and maintain quality systems for medical device manufacturing operations in Belfast. The role involves leading quality initiatives, managing non-conformances and corrective actions, and ensuring regulatory compliance across product and process excellence.

Responsibilities

• Collaborate with operations and business functions to ensure quality performance of products and processes
• Manage non-conformances and corrective/preventive actions through root cause analysis to closure
• Lead development and improvement of manufacturing processes for existing and new products
• Support execution and analysis of manufacturing complaints and product field actions
• Manage supplier relationships and monitor performance of external quality materials and services

Requirements

• Bachelor's degree (Honours) or EQF Level 6 equivalent
• 2+ years quality or regulatory affairs experience in medical device sector
• Proficiency in ISO 13485, GMP, and med device manufacturing processes
• Strong knowledge of risk management, CAPA, audits, and statistical techniques
• Advanced Microsoft Office skills and process capability analysis experience
• Fluent written and oral English at B2 level minimum
• Lean Six Sigma training highly desirable

Compensation: £36,800–£61,200 GBP annual