Job Opportunity: Senior QA Engineer
We are seeking an experienced Senior Quality Assurance Engineer to support and enhance our Quality Management System while driving quality performance across manufacturing operations. This role plays a key part in ensuring compliance with regulatory standards, leading quality improvement initiatives, and acting as a critical interface between internal teams and external stakeholders.
Job Responsibilities
Maintain and support the Quality Management System in line with ISO and regulatory standards
Lead non-conformance investigations and drive robust root cause analysis
Ensure effective implementation and timely closure of CAPAs
Support internal, customer, and regulatory audits, including preparation and follow-up
Provide day-to-day quality support to manufacturing operations
Review and approve quality documentation (e.g., batch records, protocols, reports)
Monitor quality metrics and identify opportunities for continuous improvement
Support validation activities and change control processes
Participate in customer complaint investigations and ensure timely resolution
Lead and contribute to site-wide quality improvement initiatives
Job Requirements
Third-level qualification in Science, Engineering, or a related discipline
Minimum 3+ years’ experience in a quality engineering role within manufacturing (ideally Med Device)
Proven people management experience with direct reports
Experience working in an ISO13485:2016 certified environment
Strong knowledge of Quality Management Systems, risk management tools (e.g., FMEA), and regulatory standards
Strong problem-solving, analytical, and statistical analysis skills
Excellent communication, planning, and coordination abilities
Ability to work independently and collaboratively in a fast-paced environment
High attention to detail and a strong commitment to quality and compliance
Flexible, proactive mindset with a focus on continuous improvement
For more information or to apply, please contact: Brian Stack
Email: brian.stack@collinsmcnicholas.ie
Phone: 090 9703030
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