Quality Engineer

3 weeks ago

Athlone, County Westmeath, Ireland SRG Ireland Full time

This is a fantastic opportunity to play a key role in maintaining and enhancing quality systems within a regulated environment. Youll be at the forefront of ensuring compliance, driving continuous improvement, and supporting product development in a dynamic and collaborative setting. This is a full time, permanent, onsite role. Monday to Friday on Days. Your Key Responsibilities Maintain and improve quality systems aligned with ISO 13485, ISO 9001, and applicable medical device regulations. Develop and revise SOPs and quality documentation. Conduct internal audits to ISO 13485 standards. Actively participate in customer and regulatory audits. Support new product development, including trials, sampling, and production runs. Monitor vendor performance, issue non-conformance reports (NCMRs), and implement controls to protect product integrity. Report on quality performance metrics and lead change control initiatives. Investigate and close validation deviations, non-conformances, and CAPAs. Assist in the creation and execution of validation protocols (IQ/OQ/PQ), including data analysis and test scripting. Who Youll Work With Collaborate closely with the Quality Team to share knowledge and uphold standards. Liaise with production teams to resolve quality issues and ensure smooth operations. Decision-Making Scope Make informed decisions on product quality issues flagged during production. Escalate complex problems to senior quality leadership when necessary. What You Bring Bachelors degree in Science, Engineering, or a related field. Minimum of 3 years experience as a Quality Engineer in an ISO 13485 regulated environment. Certified Internal Auditor to ISO 13485. Proven experience in equipment validation and statistical analysis. Strong interpersonal skills, attention to detail, and a proactive problem-solving mindset. Why Youll Love This Role Be part of a team that values precision, collaboration, and continuous improvement. Gain exposure to a wide range of quality assurance activities in a regulated industry. Develop your career in a supportive environment with opportunities for growth and learning. Click below to apply. Skills: Quality Engineering SPC

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