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Dublin, Éire / Ireland
Onsite
Responsibilities
Evaluate current products and processes to ensure ongoing compliance with applicable regulations and standards such as ISO 13485, 21 CFR Part 820, MDR 2017/745, IVDR 2017/746, and ISO 14971
Review and support change controls/design changes, assisting the team through the change process to maintain compliance.
Review and approval of validation deliverables for equipment and processes, and assist in implementing effective process controls.
Participate in internal and external audits, supporting audit preparation and the resolution of audit findings by liaising with process owners and managers.
Lead risk management activities, maintain risk management documentation, and help assess risk mitigation techniques, potential failure modes, defect frequency, severity, and process controls.
Collaborate with cross-functional teams to implement changes and automated systems with efficiency and accuracy.
Responsible for customer complaint handling including the implementation and follow up of corrective actions
Assist in analysing and summarizing potential issues by assessing the impact on customer safety and product quality, and contribute to decisions related to the disposition of non-conforming product.
Support the investigation of CAPAs and non-conformances, drafting and reviewing applicable records and documentation for completion at critical phases.
Stay updated on regulatory changes and industry best practices, integrating quality into all aspects of work, and offering problem-solving recommendations to the operations and engineering teams.
What are we looking for?
Experience: 2–5 years of relevant experience in a quality department within the medical device industry.
Education: Bachelor’s degree in Biomedical Engineering, Quality Management, or relevant disciplines (a Master’s degree is an advantage).
Working knowledge of ISO 13485, 21 CFR Part 820, MDR 2017/745, IVDR 2017/746, ISO 14971, IEC 62366, GAMP5, and other applicable industry standards & regulations.
Experience supporting new product introductions (Class II medical devices, Class A IVDs, Procedure Packs) and knowledge of manufacturing engineering, risk analysis, and documenting risk management files/reports.
Exposure to supplier, internal, and external audits (a professional certification in auditing is a plus).
Experience reviewing technical documentation, assisting in assessing the impact of proposed changes on the QMS, and supporting post-market surveillance activities by working constructively with stakeholders.
Knowledge of root cause analysis, continuous improvement activities, and execution/verification of effectiveness.
Familiarity with Statistics, Lean, and Six Sigma methodologies; Minitab experience is an advantage.
Strong organizational skills with the ability to support project management initiatives and foster a positive work environment.
Ability to work effectively in a fast-paced medical device manufacturing environment, multi-task, and prioritize tasks to meet high expectations and tight deadlines.
Culture: Ability to work well within cross-functional teams and promote a 'Quality Culture' where compliance is viewed as a competitive advantage.
Experience using ERP systems such as SAP S/4 HANA (Quality Management [QM] module preferred).
Strong analytical, troubleshooting, process improvement, technical writing, and verbal communication skills.
Salary and Benefits
Salary Range: €60,000 - €68,000
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.
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