Quality Engineer – QMS, CAPA & Audit Specialist

DPS Group; Dublin; On-site; EUR 55,000 - 75,000; Full time

Job summary

DPS Group is seeking an experienced Quality Engineer to support its manufacturing operations in Ireland. The role focuses on maintaining and improving the Quality Management System to meet ISO 13485 and regulatory requirements.

The successful candidate will handle CAPA, non-conformance, change control and quality system improvement across cross-functional teams, ensuring robust documentation and audit readiness.

Qualifications

• Degree in Engineering, Science, Quality or a related technical discipline.
• Quality Engineering/QA experience in regulated manufacturing.
• Strong hands-on QMS experience is essential.
• Knowledge of ISO 13485 and medical-device QMS requirements.
• Experience with CAPA, non-conformance/deviation management, change control and root cause analysis.
• Experience preparing and reviewing controlled Quality documentation.
• Experience supporting internal and/or regulatory audits.
• Knowledge of FDA Quality System requirements is advantageous.
• Medical device experience is desirable; pharmaceutical QMS experience is relevant.
• Experience with process validation, SPC or Six Sigma is beneficial.
• Strong communication across Quality, Operations and Engineering.

Responsibilities

• Provide day-to-day support for the site Quality Management System.
• Support management and continuous improvement of Quality Systems per ISO 13485 and ISO 9001.
• Manage CAPAs with effective root-cause investigations and timely closure.
• Support non-conformance investigations, incident reporting and quality records.
• Support change control activities from a Quality/compliance perspective.
• Prepare, review and maintain SOPs, QA documentation, protocols and reports.
• Participate in internal audits and support external/regulatory audits.
• Collaborate with Manufacturing, Engineering and Validation teams to stay compliant.
• Support quality investigations and implement effective root-cause analysis.
• Monitor Quality System performance and drive continuous improvement initiatives.
• Ensure adherence to GMP requirements and quality procedures.
• Provide QA input into manufacturing and process improvement activities.
• Support customer complaint and quality issue investigations as needed.

Skills

QMS experience

CAPA

Non-conformance

Change control

Root cause analysis

Auditing

Quality documentation

Cross-functional collaboration

Regulatory knowledge

Process validation / SPC / Six Sigma

Communication

Education

Bachelor's degree in Engineering, Science, or Quality

Job description

DPS Group is seeking an experienced Quality Engineer to support its manufacturing operations in Ireland. The role focuses on maintaining and improving the Quality Management System to meet ISO 13485 and regulatory requirements.

The successful candidate will handle CAPA, non-conformance, change control and quality system improvement across cross-functional teams, ensuring robust documentation and audit readiness.