Overview
Exciting opportunity now open for an experienced Quality Engineer to join Galway’s leading electronics (SMT) manufacturing company. Our client covers a number of industries including automotive, medical device and agritech. To discuss please call Rachel on 0860127415 or email (emailprotected)
About the role
38.5hr work week. Pension plan, VHI, annual leave commences at 21 days and 10 days paid sick pay
Process & Product Quality
Provide effective and responsive Quality Assurance support to Operations to ensure quality, cost and output objectives are achieved.
Drive and implement process improvements to ensure predictable and robust processes across all product lines.
Identify opportunities for risk reduction, yield improvement, customer complaint reduction, error proofing, cost reduction and process automation.
Monitor and analyse key quality metrics to identify trends and improvement opportunities.
Support the implementation and continuous improvement of the Quality Management System (QMS) across the site.
Ensure compliance with ISO 9001, ISO 13485 and applicable regulatory requirements including EU MDR, FDA and relevant regulatory agencies.
Support internal and external regulatory inspections and customer audits.
Perform internal quality audits and support audit readiness activities.
Manage and approve Engineering Change Orders (ECOs) and ensure appropriate quality review of product and process changes.
Prepare and review validation documentation including Master Validation Plans, protocols and reports.
Review and approve customer complaint investigations and analysis reports.
Work closely with Incoming Inspectors to support supplier quality management activities.
Support the investigation of supplier issues and raise Supplier Corrective Action Requests (SCARs) where required.
Support the implementation of Lean Manufacturing and continuous improvement initiatives across the site.
Lead or support root cause investigations using structured methodologies such as 8D, 5 Whys and Fishbone analysis.
Drive plant-wide quality system improvements and promote best practice in quality management.
Support product and process transfers from development or other manufacturing sites.
Qualifications & Experience
Experience
4 years + in a manufacturing or medical device environment.
Experience working within regulated manufacturing environments is highly desirable.
Education
Level 7 / Level 8 qualification in Engineering, Quality or related discipline.
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