Senior Quality Manager Position
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Galway, Ireland is home to a leading medical device manufacturer seeking an experienced Quality Assurance and Engineering Leader. The ideal candidate will have a strong background in quality management, regulatory compliance, and team leadership.
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The successful Sr. Quality Manager will be responsible for:
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* Leading the Quality Assurance, Quality Engineering, Validation, Calibration, and Microbiology teams to ensure compliance with global regulatory standards, including 21 CFR 820, ISO 13485, MDR, RDC ANVISA 16/2013, MHLW MO 169, and TG(MD)R Schedule 3.
* Developing robust systems to support design and production teams in areas such as quality planning, inspection methods, statistical analysis, sterilization, biological testing, and application of regulatory standards.
* Managing quality controls across the full product lifecycle, from raw material intake to final product release.
* Leading regulatory and customer audits and ensuring audit readiness at all times.
* Driving improvements through structured problem-solving, failure analysis, and CAPA programs.
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A degree in Engineering or a scientific discipline is required. At least 10 years of experience in a regulated medical device environment, with senior leadership exposure, is also necessary. ASQ Certified Quality Engineer (CQE) and/or Six Sigma Green/Black Belt certification is preferred.
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This is a rare opportunity to take ownership of a site-wide quality function at a senior level. You will be empowered to lead change, shape quality culture, and work in a collaborative environment where innovation, compliance, and patient safety are top priorities.
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Key Competencies:
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* Leadership & Team Management
* Regulatory Knowledge & Compliance
* Risk-Based Thinking
* Data Analysis & Statistical Applications
* Strategic Planning & Execution
* Continuous Improvement Mindset
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We offer a dynamic and supportive work environment where you can grow your career and make a real impact.
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