Quality Engineer

About Sanmina Fermoy

Our Fermoy, Ireland facility is FDA registered and certified to ISO13485:2016 for the manufacture of high‑quality PCBAs, subassemblies and complete devices up to and including Class III medical devices.

Requisition ID: 103724-0

Job Title: Quality Engineer

Department: Quality Department

Reporting To: Quality Engineering Lead

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• Primary objective is to ensure customer satisfaction by monitoring, controlling and improving all related customer processes.
  
• Principal customer interface for quality metrics and improvement initiatives.
  
• Identifies, plans and organizes regulatory affairs to ensure compliance with FDA’s Quality System Regulations, ISO 9001, ISO 13485, ISO 14001, PDML Japan Quality Management and other relevant international standards.
  

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• Management of closed‑loop customer complaints and improvement processes.
  
• Generation and review of the Quality Metrics System.
  
• Overall responsibility for DMR/DHR and Technical Files.
  
• Data collection, analysis and reporting.
  
• Pareto and trend analysis.
  
• Initiate and drive continuous improvement programs.
  
• NPI approval including First Article Inspections and reporting.
  
• CAPA, NCM and RMA analysis and improvement.
  
• QSR Validation protocols and reports (IQ, OQ & PQ).
  
• Conduct audits to ensure conformance and effectiveness of the Quality System.
  
• Assure ongoing compliance with quality and industry regulatory requirements.
  
• Ensure compliance with health and safety legislation and regulations.
  

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• Yields at key process steps.
  
• Customer Satisfaction Index (CCN, CSO etc).
  
• Customer return percentage and cost (RMA).
  
• Scrap percentage.
  
• Outgoing inspection DPM & customer incoming quality levels.
  

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• Minimum NFQ Level 7 Degree/Diploma in Science or Engineering, or a lesser qualification with sufficient job‑related experience.
  
• At least 2‑3 years of Quality Assurance / Regulatory Affairs experience in a similar Quality Engineering role in the electronics manufacturing industry is preferred.
  
• Proficient in Microsoft Word, PowerPoint and Excel.
  
• Ability to respond to common inquiries or complaints from internal customers and regulatory agencies.
  
• Ability to write standard operating procedures, training documents and regulatory responses.
  
• Experience working within a Class III Medical Device Manufacturing Environment is preferred.
  
• Six sigma Green or Black Belt Certified is preferred.
  
• Experience in New Product Introduction Processes is preferred.
  

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• Sound understanding and utilization of problem‑solving techniques. xcfaprz
  
• Strong communication and influencing skills.