Senior Principal Quality Engineer - Product Transfer & Validation

About the role

Stryker is looking for a Senior Principal Engineer, Product Transfer & Validation Quality Engineering in Cork, working in a hybrid arrangement. The role provides senior technical leadership for quality engineering activities around product transfers, manufacturing process introductions, process validation and the introduction of new technologies across the manufacturing network. It leads the development of robust, compliant and scalable quality strategies and acts as a technical authority and mentor, partnering with Product Transfer, Operations, R&D, Regulatory and Quality.

Key responsibilities

• Lead quality engineering for product transfers and technology transfers, driving the strategy from planning through qualification, validation and production readiness
• Review and guide significant product-transfer and validation decisions, and escalate risks for cross-functional resolution
• Lead risk-based validation strategies, protocols and approvals, ensuring processes and equipment meet product requirements
• Drive process risk management (including pFMEA), control plans, CTQs/CQAs and measurement system analysis
• Ensure compliance with quality management system and regulatory requirements and support resolution of systemic quality issues
• Act as a technical partner across sites, promote standardisation and knowledge sharing, and mentor Quality Engineers and junior staff

Required profile

• Bachelor's degree in Engineering, Quality, Science or a related technical discipline; an advanced technical degree is advantageous
• Significant experience in Quality Engineering, validation, product transfer or process development in a regulated environment
• Demonstrated experience leading complex product or process transfers and mentoring engineers
• Expected travel of 30%

Required skills

• Process validation, pFMEA, control plans, CTQs and CQAs
• Statistical methods, process capability and characterisation
• Technical leadership across multiple projects, functions and sites

What we offer

• Pay range in Ireland of EUR 84,000 - 139,000 per year
• Possible incentive compensation such as bonus
• Stryker's comprehensive benefits package