Quality Manager

Sterling Engineering Ltd - Ireland & Europe; Galway; On-site; EUR 70,000 - 95,000; Full time

Job summary

Sterling Engineering Ltd - Ireland & Europe is seeking a Quality Manager to lead the QMS and Design Assurance functions across the product lifecycle, including NPD, design transfer, manufacturing, and post‑market activities.

The role ensures compliance with ISO 13485, FDA 21 CFR Part 820, and EU MDR, coordinating internal audits, CAPA, and supplier quality programs while driving continuous improvement and stakeholder engagement.

Qualifications

• Bachelor’s degree in Engineering, Quality, Life Sciences or related discipline.
• 5–10 years' progressive experience in Quality Assurance/Design Assurance in the medical device industry.
• Strong knowledge of ISO 13485, FDA 21 CFR Part 820, EU MDR and medical device QMS.

Responsibilities

• Lead and maintain the QMS, ensuring regulatory and customer compliance.
• Represent Quality within NPD, design transfer, manufacturing and post‑market activities.
• Coordinate CAPA, internal audits, management reviews and continuous improvement initiatives.
• Act as primary quality contact during customer audits, supplier assessments and regulatory inspections.

Skills

Leadership

Quality management

Regulatory knowledge

Stakeholder management

Technical writing

Education

Bachelor's degree in Engineering/Quality/Life Sciences

Job description

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.