Quality Engineer (QMS)

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

Quality Engineer – QMS

Role Overview

We are seeking an experienced Quality Engineer with strong Quality Management System (QMS) experience to support its manufacturing operations.

The successful candidate will provide Quality Engineering support across the site, with particular focus on maintaining and improving the Quality Management System, ensuring compliance with internal procedures and applicable regulatory requirements.

This role would suit an experienced Quality Engineer or QA professional from a medical device, pharmaceutical or similarly regulated manufacturing environment with hands-on experience in CAPA, non-conformance, change control, auditing and quality system improvement.

Key Responsibilities

• Provide day-to-day support for the site Quality Management System.
• Support the management and continuous improvement of Quality Systems in accordance with ISO 13485, ISO 9001 and applicable regulatory requirements.
• Manage and support CAPAs, ensuring effective root cause investigation, corrective actions and timely closure.
• Support non-conformance investigations, incident reporting and associated quality records.
• Support change control activities and assess changes from a Quality and compliance perspective.
• Prepare, review and maintain SOPs, Quality System documentation, protocols, reports and other controlled documentation.
• Participate in internal audits and support external/regulatory audits.
• Work closely with Manufacturing, Engineering, Validation and other cross-functional teams to ensure ongoing compliance.
• Support quality investigations and the implementation of effective root cause analysis.
• Monitor Quality System performance and support continuous improvement initiatives.
• Ensure adherence to site GMP requirements and quality procedures.
• Provide Quality input into manufacturing and process improvement activities.
• Support customer complaint and quality issue investigations where required.

Qualifications & Experience

• Degree in Engineering, Science, Quality or a related technical discipline.
• Previous Quality Engineering / Quality Assurance experience within a regulated manufacturing environment.
• Strong hands-on QMS experience is essential.
• Good working knowledge of ISO 13485 and medical-device Quality System 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 would be advantageous.
• Medical device experience is highly desirable, although strong pharmaceutical Quality Systems experience would also be relevant.
• Experience with process validation, statistical methods/SPC or Six Sigma would be beneficial.
• Strong communication skills with the ability to work effectively across Quality, Operations and Engineering functions.