Quality Manager

Sterling Engineering; Galway; On-site; EUR 90,000 - 120,000; Full time

Job summary

Sterling Engineering in Galway, Ireland, seeks an experienced Quality Manager to lead the QMS and Design Assurance across the full product lifecycle in a medical device environment.

You will drive regulatory compliance, CAPA, risk management and continuous improvement, building high-performing teams and ensuring patient safety. This senior role requires strong leadership and collaboration with cross-functional teams and external partners.

Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, or a related discipline.
• 510 years' progressive experience in Quality Assurance, Design Assurance, and/or Quality Systems within the medical device industry.
• Proven leadership experience managing quality and compliance functions.
• Strong working knowledge of ISO 13485, FDA 21 CFR Part 820/QMS requirements, EU MDR, and medical device quality systems.
• Experience with Design Controls, Design Assurance, Risk Management, Verification & Validation, and Design Transfer.
• Solid 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, and supplier quality programmes.
• Excellent communication, technical writing, presentation, and stakeholder management skills.

Responsibilities

• Lead, maintain, and continuously improve the Quality Management System (QMS) in compliance with applicable regulatory and customer requirements.
• Provide leadership across Quality Assurance, Quality Control, and Design Assurance functions.
• Represent Quality on cross-functional New Product Development (NPD) teams, ensuring quality and regulatory requirements are integrated throughout the product lifecycle.
• Ensure Design Controls, Risk Management, Verification & Validation (V&V), and Design Transfer activities are effectively implemented and maintained.
• Review and approve quality and design documentation, including risk management files, validation documentation, engineering changes, and product transfer activities.
• Lead core quality processes including Management Review, Internal Audits, CAPA, Complaint Handling, Non-conformance Management, and Continuous Improvement initiatives.
• Ensure product, process, and supplier quality requirements are established, monitored, and maintained to meet regulatory and customer expectations.
• Act as the primary quality representative during customer audits, supplier audits, certification audits, and regulatory inspections.
• Drive quality performance through the effective use of KPIs, risk management methodologies, and continuous improvement programmes.
• Lead, mentor, and develop the Quality team while fostering a culture of quality, compliance, accountability, and operational excellence.
• Manage departmental priorities, resources, and employee performance to support business objectives.
• Exercise quality authority to stop production, product release, or shipment where quality, regulatory compliance, or patient safety may be at risk.

Skills

Leadership

Regulatory knowledge

Quality management

Stakeholder management

Education

Bachelor's degree in Engineering

Job description

Job Description

We are seeking an experienced Quality Manager to lead the Quality Management System (QMS) and Design Assurance function for a growing medical device manufacturing organisation. This is a senior leadership role responsible for ensuring compliance with regulatory, customer, and business requirements while providing quality oversight throughout the entire product lifecyclefrom New Product Development (NPD) and design transfer through manufacturing and post-market support. The successful candidate will be passionate about quality, compliance, continuous improvement, and developing high-performing teams within a regulated medical device environment.

Key Responsibilities

• Lead, maintain, and continuously improve the Quality Management System (QMS) in compliance with applicable regulatory and customer requirements.


• Provide leadership across Quality Assurance, Quality Control, and Design Assurance functions.


• Represent Quality on cross-functional New Product Development (NPD) teams, ensuring quality and regulatory requirements are integrated throughout the product lifecycle.


• Ensure Design Controls, Risk Management, Verification & Validation (V&V), and Design Transfer activities are effectively implemented and maintained.


• Review and approve quality and design documentation, including risk management files, validation documentation, engineering changes, and product transfer activities.


• Lead core quality processes including Management Review, Internal Audits, CAPA, Complaint Handling, Non-conformance Management, and Continuous Improvement initiatives.


• Ensure product, process, and supplier quality requirements are established, monitored, and maintained to meet regulatory and customer expectations.


• Act as the primary quality representative during customer audits, supplier audits, certification audits, and regulatory inspections.


• Drive quality performance through the effective use of KPIs, risk management methodologies, and continuous improvement programmes.


• Lead, mentor, and develop the Quality team while fostering a culture of quality, compliance, accountability, and operational excellence.


• Manage departmental priorities, resources, and employee performance to support business objectives.


• Exercise quality authority to stop production, product release, or shipment where quality, regulatory compliance, or patient safety may be at risk.

Requirements

• Bachelor's degree in Engineering, Quality, Life Sciences, or a related discipline.


• 510 years' progressive experience in Quality Assurance, Design Assurance, and/or Quality Systems within the medical device industry.


• Proven leadership experience managing quality and compliance functions.


• Strong working knowledge of ISO 13485, FDA 21 CFR Part 820/QMS requirements, EU MDR, and medical device quality systems.


• Experience with Design Controls, Design Assurance, Risk Management, Verification & Validation, and Design Transfer.


• Solid 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, and supplier quality programmes.


• Excellent communication, technical writing, presentation, and stakeholder management skills.


• Ability to work collaboratively across multidisciplinary teams and build strong relationships with customers and external partners.