Senior Quality Engineer
Undefined
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16 Oct 2025
Galway, County Galway, Ireland
Verified by Turrior
Content + Source + Freshness • 11 Dec 2025 • 95% confidence
85 / 100
Offer value
Excellent value due to leadership role, regulatory compliance focus, and opportunities in digital transformation within a reputable organization.
- Lead role with mentoring opportunities in quality engineering
- Focus on digital transformation and regulatory compliance
- Engagement in industry-leading quality management practices
Pros
- High-level role with opportunity to lead and mentor within quality engineering
- Focus on cutting-edge digital quality systems and continuous improvement
- Engagement with regulatory compliance, enhancing job stability
Cons
- May involve high accountability and pressure due to regulatory requirements
- Potentially extensive workload related to audits and compliance checks
- Unclear salary range may deter some candidates
Who it's for
Senior / Lead • Hybrid / office interactions
Good fit
- Experienced quality engineers looking to take a leadership role
- Professionals keen on digital transformation initiatives
- Individuals with knowledge of regulatory quality standards
Not recommended for
- Entry-level professionals without relevant experience
- Candidates who prefer minimal responsibilities
- Those who do not wish to engage in compliance activities
Motivation fit
Desire to innovate in quality assurance processesInterest in regulatory compliance and digital toolsMotivation to work in a structured, compliance-focused environment
Key skills
Quality Management Systems (QMS)Regulatory compliance knowledge (FDA, ISO 13485)Team leadership and mentorshipExperience with digital quality systems
Score: 85/100 AI verified analysis
About the job
Senior Quality Engineer
Overview
We are seeking an experienced Senior Quality Engineer to lead digital quality initiatives and support the integration of automated, data-driven processes across manufacturing and quality systems. This role will ensure regulatory compliance (FDA, EU MDR, ISO 13485) and drive continuous improvement of digital workflows, MES, ERP, and eLHR systems.
Key Responsibilities
Overview
We are seeking an experienced Senior Quality Engineer to lead digital quality initiatives and support the integration of automated, data-driven processes across manufacturing and quality systems. This role will ensure regulatory compliance (FDA, EU MDR, ISO 13485) and drive continuous improvement of digital workflows, MES, ERP, and eLHR systems.
Key Responsibilities
- Maintain and improve the Quality Management System (QMS) in line with ISO 13485 and FDA standards.
- Lead and mentor a small team while supporting digital transformation of quality processes.
- Ensure compliance with regulatory requirements and data integrity across digital platforms.
- Collaborate with cross-functional teams to embed quality assurance into MES, ERP, and other systems.
- Conduct and support IQ/OQ/PQ validation for digital equipment and software.
- Manage CAPAs, SCARs, and non-conformance documentation; support internal and external audits.
- Implement and monitor predictive analytics and AI tools for quality improvement.
- Provide guidance on data governance, cybersecurity, and traceability.
- Ensure compliance with 21 CFR Part 11 and electronic records validation.
- Bachelor’s degree in Engineering, Quality, or a related field.
- 5+ years of experience in quality engineering within a regulated manufacturing environment.
- Strong understanding of FDA, ISO 13485, and EU MDR standards.
- Experience with digital quality systems, MES, ERP, and eLHR.
- Excellent communication skills across technical and non-technical teams.
- Knowledge of DHR/DMR processes and digital documentation systems preferred.
