Senior QA Engineer

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

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