Senior Quality Engineer

Senior Quality Engineer

We are seeking a detail-oriented Senior 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 reviewing and approving change controls, validating manufacturing equipment and processes, participating in audits, leading risk management activities, and providing mentorship to the Quality team. 

Responsibilities include, but are not limited to, the following: 

• Evaluate current products and processes to ensure compliance with applicable regulations and standards.
• Review and approve change controls, guiding the team through the change process to maintain compliance.
• Review and approve validation deliverables for manufacturing equipment and processes and identify effective process controls.
• Participate in internal and external audits, taking on various roles within the audit team and leading audit preparation, resolution of audit findings by liaising with process owners and managers. 
• Lead risk management activities, maintain risk management documentation and assess risk mitigation techniques, identify potential failure modes, defect frequency, severity, risk, process controls, etc. 
• Collaborate with cross-functional teams to implement changes and automated production systems for efficient quality issue resolution. 
• Provide mentorship to Quality team personnel on meeting daily work priorities and team goals with direction from management and technical guidance in identifying and resolving quality issues using six sigma, lean, and related tools/techniques. 
• Responsible for analyzing and summarizing potential issues by assessing impact on customer safety and product quality and to make decisions related to the disposition of non-conforming product. 
• Contribute towards investigation of CAPAs and non-conformances and review 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 we are looking for…

• Minimum 5 years of relevant experience in an engineering or quality role, or an advanced degree preferably in Quality, Biomedical Engineering with a minimum 3 years of experience in a quality department.
• Good working knowledge of ISO 13485, 21 CFR Part 820, MDR 2017/745, IVDR 2017/746, ISO 14971
• Proficient in using SAP S/4 HANA, particularly the Quality Management (QM) module
• Experience with internal and external audits, and a professional certification in Quality Auditing (i.e. Certified Lead Auditor or Internal Auditor) is required.
• Experience in reviewing technical documentation, assessing impact of proposed changes on the QMS by working constructively with stakeholders across all business areas of the organization. 
• Experience with new product introduction (Class II medical devices, Class A IVDs) and have significant expertise in validation engineering, risk analysis and documenting risk management reports. 
• Knowledge of root cause analysis, continuous improvement activities and execution and verification of effectiveness techniques. 
• Hands-on using Statistics, Lean and Six Sigma methodologies is required, Minitab experience is an advantage.
• Ability to work independently in a fast-paced medical device manufacturing environment, and able to multitask and prioritize tasks to meet high expectations and tight deadlines.
• Project and people management skills are needed, along with the ability to mentor the team and foster a positive work environment. 
• Excellent analytical, troubleshooting, process improvement, critical thinking, and decision-making skills.
• Strong technical writing and exceptional verbal communication skills

Benefits: 

Alongside a base salary of €50,000 - €55,000 we offer a range of benefits including: 

• Health insurance and an Employee Assistance Programme 
• Pension matching contribution
• Annual Compensation Reviews 
• After 90 days you will be eligible to avail of Flexible Annual Leave where you are not restricted to a specific number of holiday days / annual leave
• Free monthly LetsGetChecked tests as we are not only focused on the well being of our patients but also the well being of our teams
• 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.  
• Bike to work scheme - and secure bike storage onsite. 
• Maternity, Paternity, Parental and Wedding leave.

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