Quality Manager

Sterling Engineering Ltd - Ireland & Europe; Galway; On-site; EUR 90,000 - 120,000; Full time

Job summary

Sterling Engineering Ltd in Galway seeks a Quality Manager to lead the QMS and Design Assurance across the product lifecycle, from NPD to post-market. You will ensure compliance with ISO 13485, EU MDR, and regulatory requirements while guiding cross-functional teams.

You will manage internal audits, CAPA, risk management, V&V, and liaison with customers and regulators. The role demands strong leadership, technical writing, and stakeholder management skills in a medical device environment.

Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, or related.
• 5-10 years' progressive experience in QA/Design Assurance within the medical device industry.
• Leadership experience managing quality and compliance functions.
• Strong knowledge of ISO 13485, FDA 21 CFR Part 820, EU MDR, and medical device quality management systems.
• Experience with Design Controls, Design Assurance, Risk Management, Verification & Validation (V&V), and Design Transfer processes.
• Good understanding of ISO 14971 risk management principles.
• Experience maintaining Design History Files (DHF), Technical Documentation, Risk Management Files, and Device Master Records (DMR).
• Excellent technical writing, communication, presentation, and stakeholder management skills.

Responsibilities

• Lead and maintain the Quality Management System (QMS), ensuring compliance with applicable regulatory, customer, and business requirements.
• Provide leadership across Quality Assurance, Quality Control, and Design Assurance throughout product development, manufacturing, and post-market support.
• Represent Quality within New Product Development (NPD) teams; integrate quality and regulatory requirements throughout the lifecycle.
• Ensure Design Controls, Risk Management, V&V, and Design Transfer activities are effectively implemented.
• Review and approve quality and design documentation, including risk management files, validation protocols, and change documentation.
• Lead Management Reviews, Internal Audits, CAPA, Complaint Handling, and Continuous Improvement initiatives.
• Establish and monitor product, process, and supplier quality requirements to meet customer expectations and regulatory standards.
• Act as the primary quality contact during customer audits, supplier assessments, and regulatory inspections.
• Monitor quality performance using metrics and risk management processes.
• Lead, coach, and develop the Quality team; foster a culture of compliance and continuous improvement.
• Manage departmental priorities, resources, and employee performance to support organisational objectives.
• Exercise authority to halt production, release, or shipment where quality or patient safety may be compromised.

Skills

Leadership

Quality Assurance

Regulatory knowledge

Stakeholder management

Communication

Education

Bachelor's degree in Engineering, Quality, Life Sciences, or related

Tools

QMS software

Job description

Quality Manager - Galway

The Quality Manager is responsible for leading, developing, implementing, and maintaining the Quality Management System (QMS) and Design Assurance function. This role ensures compliance with applicable regulatory, customer, and business requirements while providing quality oversight throughout the product lifecycle, including New Product Development (NPD), design transfer, manufacturing, and post-market activities.

Key Responsibilities

• Lead and maintain the Quality Management System (QMS), ensuring compliance with applicable regulatory, customer, and business requirements.
• Provide leadership and direction across Quality Assurance, Quality Control, and Design Assurance functions throughout product development, manufacturing, and post-market support.
• Represent Quality within New Product Development (NPD) teams, ensuring quality and regulatory requirements are integrated throughout the product lifecycle.
• Ensure effective implementation and maintenance of Design Controls, Risk Management, Verification & Validation (V&V), and Design Transfer activities.
• Review and approve quality and design documentation, including risk management files, validation protocols and reports, engineering change documentation, and product transfer deliverables.
• Lead Management Reviews, Internal Audits, Corrective and Preventive Actions (CAPA), Complaint Handling, Non-Conformance management, and Continuous Improvement initiatives.
• Establish, monitor, and maintain product, process, and supplier quality requirements to meet customer expectations and regulatory standards.
• Act as the primary quality contact during customer audits, supplier assessments, certification audits, regulatory inspections, and product development activities.
• Monitor quality performance through the use of metrics, risk management processes, and continuous improvement programmes.
• Lead, coach, and develop the Quality team, fostering a culture of compliance, accountability, quality excellence, and continuous improvement.
• Manage departmental priorities, resources, and employee performance to support organisational objectives.
• Exercise the authority to halt production, product release, or shipment where quality, regulatory compliance, or patient safety may be compromised.

Qualifications & Experience

• Bachelor's degree in Engineering, Quality, Life Sciences, or a related discipline.
• 5-10 years' progressive experience in Quality Assurance, Design Assurance, and/or Quality Systems within the medical device industry.
• Demonstrated leadership experience managing quality and compliance functions.
• Strong knowledge of ISO 13485, FDA 21 CFR Part 820, EU MDR, and medical device quality management systems.
• Practical experience with Design Controls, Design Assurance, Risk Management, Verification & Validation (V&V), and Design Transfer processes.
• Good understanding of ISO 14971 risk management principles and methodologies.
• Experience maintaining Design History Files (DHF), Technical Documentation, Risk Management Files, and Device Master Records (DMR).
• Experience supporting customer audits, regulatory inspections, supplier quality programmes, and certification audits.
• Excellent technical writing, communication, presentation, and stakeholder management skills.
• Strong collaboration skills with the ability to work effectively across cross-functional teams and with external stakeholders.