Quality Systems Engineer

3 weeks ago

Galway, Galway, Ireland GI Group Full time
Job Title : Quality Systems Engineer Location: Galway Salary: 60-70k This a full time permanent role Our client is a well established Medical Device Manufacturing organisation in the heart of Galway city.
Due to rapid expansion, they are looking for a QS Engineer to join their team.
The ideal candidate will have experience with QS systems and internal and external audits.
The role will provide exposure to all activities across the Quality team.
Responsibilities: Ensure compliance of Quality Management System (QMS) with applicable regulations and standards Conduct gap assessments and implement necessary actions to align QMS with regulatory expectations.
Maintain the annual audit schedule Coordinate internal and external audits Track audit findings through to resolution Serve as the Coordinator for CAPA and Complaint processes: Manage software validation activities and ensure the electronic QMS remains in a validated state.
Collect and analyze quality data to support monthly reporting and Management Review processes.
Monitor progress of quality system actions, escalate delays, and support mitigation planning with senior stakeholders.
Drive continuous improvement of QMS processes across the organization.
Act as a key quality liaison for cross-functional teams, ensuring compliance and promoting quality culture.
Coordinate the Temporary Authorisation process and related activities.
Manage supplier quality processes, including selection, approval, monitoring, and performance reporting.
Support additional quality initiatives and regulatory submissions as needed.
Education & Training Minimum of a Diploma in Engineering, Science, or Quality Assurance.
Additional training or certification in Quality Systems, Risk Management, CAPA, Auditing, or Medical Device Regulations is highly desirable.
At least 2 years of relevant experience in the medical device or pharmaceutical industry.
Working knowledge of ISO 13485, ISO 14971, EU MDR 2017/745, and FDA QSRs is preferred.
Strong communication and organizational skills, with attention to detail in documentation and reporting.
Experience in managing QMS activities such as audits, software validation, complaints, risk management, and CAPA is advantageous.
KSGalway Should you require any support or assistance, please contact your local Gi Group office.
Gi Group Holdings Recruitment Limited are proud founding members of Menopause in business, pledge members for Neurodiversity in business, Disability committed members, Silver status pledge members for the Armed Forces Covenant, and Bronze trail blazers for Racial Equality matters.
Gi Group Holdings Recruitment Limited group of companies includes Gi Recruitment Limited, Draefern Limited, Gi Group Recruitment Ltd, INTOO (UK) Limited, Marks Sattin (UK) Limited, TACK TMI UK Limited, Grafton Professional Staffing Limited, Encore Personnel Services, Gi Group Ireland Limited and Kelly Services (UK) Ltd.
Gi Group Ireland Limited are acting as an Employment Agency in relation to this role.
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If you choose to apply, your information will be processed in accordance with the Gi Group Privacy Statement.
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Skills: Quality engineering pharmaceutical

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