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Dublin, Éire / Ireland
Onsite
QMS Governance & Regulatory Compliance: Serve as designated Management Representative and Person Responsible for Regulatory Compliance (PRRC) on behalf of the Director of Manufacturing Quality and Regulatory. Ensure site compliance with EN ISO 13485:2016, 21 CFR 820, EU MDR (2017/745), EU IVDR (2017/746), and applicable regional requirements.
eQMS & Change Control: Oversee the implementation, operation, and maintenance of the eQMS platform. Manage document and design change control processes to ensure compliance with company protocols.
Team Leadership & Development: Manage Quality personnel, allocating work and managing projects to achieve site goals. Design, assign, and lead comprehensive QMS, product, and capability training to embed problem prevention and quality standards across the organization.
Risk Management: Maintain and participate in the Risk Management program (EN ISO 14971), identifying critical-to-quality procedures for each product and leading quarterly risk file updates.
Audits & Management Review: Lead the internal audit program, participate in third-party regulatory audits, and collate site management reviews across all locations to support QMS continuous improvement.
CAPA & Continuous Improvement: Drive quality performance using CAPA, Kaizen, NCR, and root-cause analysis methodologies, focusing specifically on technical issue resolution and customer complaint reduction.
Performance Reporting & Best Practices: Maintain KPI reporting methodologies across all scoped locations. Collaborate with sister sites to share and establish quality management best practices.
Operational & Project Execution: Execute assigned projects (design and continuous improvement) within budget and schedule, incorporating Lean, Six Sigma, safety, and cost-reduction principles.
Site Support & Travel: Travel nationally and internationally as needed, providing backup support to sister locations and performing additional duties as assigned.
Minimum Qualifications
Bachelor’s degree in Quality Management, Engineering, or a technical discipline (or equivalent practical experience).
IRCA Certified Lead Auditor (EN ISO 13485:2016).
5+ years of experience as a Quality Manager in a medical device or IVD environment.
Preferred Experience & Technical Skills
Hands-on experience with medical device software, electromechanical devices, sterilization processes, and regulatory submissions.
Formal training in Risk Management (EN ISO 14971:2019).
Proven leadership experience managing directly reporting teams.
Experience working within controlled room / cleanroom environments.
Strong cross-functional collaboration skills (working with Regulatory Affairs, Engineering, and Materials).
Customer Focus: Understands internal and external customer needs, prioritizes prompt resolution, and makes business decisions with customer satisfaction in mind.
Drive for Results: Highly motivated to achieve quantifiable business outcomes. Bottom-line oriented, understands organizational profitability, and acts with strict professional ethics.
Adaptability: Copes effectively with organizational change and workplace uncertainty, actively seeking clarification when needed and demonstrating openness to new procedures and technology.
Creative Problem-Solving: Identifies root causes, recognizes operational patterns, and generates novel, effective solutions to complex issues.
Cross-Cultural Respect & Collaboration: Respects diverse viewpoints and backgrounds, fostering strong, collaborative relationships across all levels of the business.
Salary and Benefits
Salary Range: €80,000 - €85,000
Benefits - Fuze Health
Health insurance and an Employee Assistance Programme
Pension
Annual Compensation Reviews
A referral bonus programme to reward you for helping us hire the best talent
Internal Opportunities and Careers Clinics to help you progress your career within the company
Maternity, Paternity, Parental and Wedding leave
LetsGetChecked has a flexible annual leave policy
#LI-Onsite
Equal Opportunity Employer
Fuze Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, gender identity, sexual orientation, age, disability, veteran status, or any other legally protected basis. If you have a disability and require reasonable accommodation during any portion of the application or hiring process, please contact us at talent@fuzehealth.com.
Fuze Health considers qualified applicants with arrest or conviction records for employment and conducts background checks consistent with applicable law, including the California, Los Angeles County, San Francisco, Philadelphia, and New York City Fair Chance laws. We are an E-Verify participating company.
Use of Automated Decision Tools
Fuze Health recruiters and hiring managers may use automated decision tools to help identify candidates who match the stated job requirements, and to what extent. These tools are designed to help ensure fairness in all aspects of the hiring process by providing recruiters and hiring managers with data-backed insights based on information provided in your resume, including work experience, education, and other skills. Fuze Health does not use automated decision tools to make hiring decisions; hiring decisions always involve human review and input. If you have any questions or would like to request an alternative process, please contact us at talent@fuzehealth.com.
Privacy Notice
To learn about Fuze Health’s privacy practices, including compliance with applicable privacy laws, please read our Privacy Notice for Job Applicants.
