Quality Engineer - Fuze Services - Fixed Term Contract

About the role

We are seeking a detail-oriented Quality Engineer to join our dynamic team at our Manufacturing Facility in Dublin to ensure our products and processes comply with relevant regulations and standards, including ISO 13485, 21 CFR Part 820, MDR 2017/745, IVDR 2017/746, and ISO 14971. This role involves supporting change controls, participating and reviewing validations related to manufacturing equipment and processes, supporting and contributing to internal and external audits, leads risk management activities, and collaborating closely with the teams involved in the product life cycle. This is a 12 Months Fixed Term Contract, based onsite in our Dublin 11 facility.

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

Requirements

• 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
• 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
• 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