Position / Title: Quality Engineer
Reports to: Senior Quality Engineer
Position Summary:To support the Senior Quality Engineer in the activities associated with Product Manufacture and Lot Release, as outlined below.
• Providing support to, and interacting with, the Finished Device Manufacturing Subcontractor in order to ensure that product quality requirements are achieved.
• Providing support to, and interacting with, suppliers in order to ensure that component and material quality requirements are achieved.
• Performing Lot review and Lot release activities.
• Ensuring that Product manufacture and release activities are performed in a manner that is compatible with the regulatory requirements as outlined below and business needs.
• Providing support to the distribution network, as required, in order to manage product quality, traceability and other items as required.
• Auditing of Subcontractors and Suppliers.
• Ensuring that SCAR’s, CAPAs, NC’s and other open action items, are completed in a thorough and timely manner.
• Processing change requests ensuring product impact is assessed.
Supporting Risk Management activities as required
• Support the Complaint coordinator in evaluation / investigation of product complaints, where required.
• Support R&D and Design Assurance in development activities where they interact with the above principal responsibilities.
Training / Qualifications in CAPA, Auditing, Risk Management and Medical Device Regulations is highly desirable.
• Ideally 2 -4 years’ experience in a medical device manufacturing environment.
• Experience interacting with subcontractors is desirable.
• Auditing experience, both internally and of suppliers is desirable.
• Excellent attention to detail, communication skills, people and team working skills
• Good problem solving skills.
Regulatory / Quality Requirements:
• ISO 13485
• ISO 14155
• 21 CFR 820
• 21 CFR Parts 50, 54, 56, 812
• ICH GCP
• Quality Management System
• Risk Management (including FMECA)
Maintain excellent relationships and channels of communication with Manufacturing Subcontractors, Suppliers and other bodies, as appropriate to meet responsibilities of the position. This may involve some travel as required for auditing and supplier support.
Clodagh Nerney | Tel: +353 (0) 1 507 9254