Principal Quality Engineer, Product Transfer & Validation

Stryker; Cork; Hybrid; EUR 84,000 - 139,000; Full time

Benefits offered by this job

Incentive compensation

Comprehensive benefits package

Job summary

Stryker in Ireland seeks a Senior Principal Engineer for Product Transfer & Validation Quality Engineering to lead quality activities across transfers, validation and new technologies in the manufacturing network. You will set robust quality strategies and mentor teams while balancing regulatory requirements and business needs.

You will provide technical direction, oversee risk-based validation, drive process control, and work cross-functionally with Operations, R&D, Regulatory and Quality to

Qualifications

• Bachelor's degree in Engineering or a related technical discipline; an advanced technical degree is advantageous.
• Significant experience in Quality Engineering, engineering, validation, product transfer or process development within a regulated environment.
• Demonstrated experience leading technically complex product or manufacturing process transfers.
• Strong practical experience in process validation, risk management and statistical Quality Engineering techniques.
• Experience developing and reviewing validation strategies and technical documentation.
• Experience working across multiple functions and manufacturing locations.
• Demonstrated ability to mentor engineers and provide technical leadership at organisational level.

Responsibilities

• Provide senior Quality Engineering leadership for product transfers, manufacturing process introductions and technology transfers across manufacturing sites.
• Develop and drive the Quality Engineering strategy for complex transfer programmes from initial planning through process qualification, validation and production readiness.
• Ensure quality requirements and deliverables are incorporated into project plans, design-transfer activities and key project milestones.
• Provide independent technical review, challenge and guidance on significant product-transfer and validation decisions.
• Develop solutions to complex technical and compliance challenges, particularly where conflicting technical, regulatory or business constraints exist.
• Identify and escape significant product, process or quality-system risks and drive appropriate cross-functional resolution.
• Provide technical leadership for the development and execution of risk-based validation strategies for manufacturing processes, equipment, inspection methods and associated systems.
• Lead and support validation planning, protocol development, execution, technical review and approval.
• Ensure validation activities demonstrate that manufacturing processes and equipment are capable of meeting defined product and process requirements.
• Provide technical oversight of complex validation challenges and ensure appropriate scientific and statistical rationale supports validation decisions.
• Drive consistency and best practice in validation approaches across Product Transfer Quality Engineering.
• Lead the development and application of process risk management, including PFMEA, to identify and mitigate manufacturing and product risks.
• Ensure identified risks are translated into process controls, inspection strategies and validation requirements.
• Drive robust inspection and control strategies incorporating Critical Quality Attributes (CQAs), Critical-to-Quality characteristics (CTQs) and Measurement System Analysis (MSA).
• Ensure control strategies support effective process characterisation, capability assessment, ongoing process control and early identification of process deterioration.
• Promote risk-based decision-making throughout the product-transfer lifecycle.
• Ensure Product Transfer and validation activities comply with applicable Quality Management System and regulatory requirements.
• Ensure robust and compliant product-transfer documentation, providing clear evidence that manufacturing requirements have been established, verified and transferred.
• Provide technical Quality Engineering input into procedures, standards and processes supporting product transfer and validation.
• Ensure systems and processes are established to protect product quality, patient safety and regulatory compliance.
• Support the identification and resolution of systemic quality or compliance issues arising during transfer and validation.
• Act as a senior technical partner to Product Transfer, Validation, Operations, R&D, Regulatory and Quality teams.
• Provide technical Quality Engineering direction across sending and receiving sites during product transfers.
• Facilitate effective technical decision-making between functions and manufacturing locations.
• Promote standardisation, knowledge sharing and application of best practices across the manufacturing network.
• Serve as a technical authority and subject-matter expert for Product Transfer and Validation Quality Engineering.
• Mentor and coach Quality Engineers and junior engineering personnel in validation, process risk management, problem solving and Quality Engineering principles.
• Develop the technical capability of the wider Quality Engineering organisation through coaching, technical reviews and knowledge sharing.
• Influence technical decisions across functions and sites without reliance on direct organisational authority.
• Promote a culture of technical excellence, accountability, continuous improvement and compliance.

Skills

Quality Engineering

Product Transfer

Process Validation

Risk Management

CQAs/CTQs

Statistical Methods

Cross-functional Leadership

Technical Leadership

Education

Bachelor's degree in Engineering or related field

Job description

Stryker in Ireland seeks a Senior Principal Engineer for Product Transfer & Validation Quality Engineering to lead quality activities across transfers, validation and new technologies in the manufacturing network. You will set robust quality strategies and mentor teams while balancing regulatory requirements and business needs.

You will provide technical direction, oversee risk-based validation, drive process control, and work cross-functionally with Operations, R&D, Regulatory and Quality to