Senior QMS Quality Engineer - Medical Device & ISO 13485

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

Job summary

DPS Group Global is seeking an experienced Quality Engineer to support its manufacturing operations in Ireland. The role focuses on maintaining and improving the Quality Management System (QMS), ensuring compliance with internal procedures and regulatory requirements.

The ideal candidate has hands-on QMS experience in medical devices or pharma, with CAPA, non-conformance, change control, audits and quality system improvement. Strong cross-functional collaboration is essential.

Qualifications

• Degree in Engineering, Science, Quality or a related technical discipline.
• Experience as Quality Engineer/QA in a regulated manufacturing environment.
• 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 supporting internal and/or regulatory audits.
• Knowledge of FDA QMS requirements would be advantageous.
• Medical device experience is desirable; pharmaceutical QMS experience relevant.
• Process validation, SPC or Six Sigma knowledge would be beneficial.

Responsibilities

• Provide day-to-day support for the site Quality Management System.
• Support the management and continuous improvement of Quality Systems per ISO 13485 and ISO 9001.
• Manage and support CAPAs with root cause investigation and timely closure.
• Support non-conformance investigations and incident reporting.
• Assist change control activities from a Quality perspective.
• Prepare, review and maintain SOPs and controlled documentation.
• Participate in internal and external/regulatory audits.
• Collaborate with Manufacturing, Engineering, Validation and cross-functional teams.

Skills

QMS experience

Regulatory compliance

CAPA & non-conformance

Audit support

Root cause analysis

Education

Engineering/Science/Quality degree

Job description

DPS Group Global is seeking an experienced Quality Engineer to support its manufacturing operations in Ireland. The role focuses on maintaining and improving the Quality Management System (QMS), ensuring compliance with internal procedures and regulatory requirements.

The ideal candidate has hands-on QMS experience in medical devices or pharma, with CAPA, non-conformance, change control, audits and quality system improvement. Strong cross-functional collaboration is essential.