Quality Engineer

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 or email [emailprotected]

38.5hr work week. Pension plan, VHI, annual leave commences at 21 days and 10 days paid sick pay

• 
  
• 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.
  

• 
  
• 4 years + in a manufacturing or medical device environment.
  
• Experience working within regulated manufacturing environments is highly desirable. xcfaprz
  

• 
  
• Level 7 / Level 8 qualification in Engineering, Quality or related discipline.