Quality Engineer

About the Role and Company

This role is based at Sanmina's facility in Fermoy, County Cork, Ireland, which is FDA registered and holds ISO 13485:2016 certification. The site specializes in manufacturing high-quality PCBAs, subassemblies, and complete medical devices including Class III products. Sanmina Fermoy offers end-to-end services covering New Product Introduction (NPI), prototyping, process validation, volume manufacturing, testing, shipping, and repair. The facility boasts 30 years of exceptional operational performance guided by an experienced workforce.

Primary Responsibilities

• Ensure customer satisfaction through monitoring, controlling, and enhancing customer-related processes.
• Act as the main customer liaison for quality metrics and continuous improvement initiatives.
• Manage regulatory compliance with FDA Quality System Regulations, ISO 9001, ISO 13485, ISO 14001, and PDML Japan Quality Management, alongside other international standards relevant to customer products.
• Oversee closed-loop customer complaint management and improvement processes.
• Generate and review quality metrics systems.
• Maintain responsibility for Device Master Records (DMR), Device History Records (DHR), and Technical Files.
• Gather, analyze, and report data including Pareto and trend analysis.
• Initiate and drive continuous improvement programs.
• Approve new product introductions including First Article Inspections and reporting.
• Analyze and improve Corrective and Preventive Actions (CAPA), Non-Conformance Material (NCM), and Returned Material Authorization (RMA) processes.
• Develop and report Quality System Regulation (QSR) validation protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Conduct audits to verify compliance and effectiveness of the quality system.
• Ensure continuous compliance with quality standards and industry regulatory requirements.
• Comply with Health & Safety legislation and regulations.

Key Performance Indicators

• Yields at critical process steps.
• Customer Satisfaction Indices including Customer Complaint Notification (CCN) and Customer Service Order (CSO).
• Percentage and cost of customer returns (RMA).
• Scrap percentage.
• Outgoing inspection defect parts per million (DPM) and customer incoming quality levels.

Qualifications and Experience

• Minimum Level 7 NFQ Degree or Diploma in Science or Engineering, or equivalent experience in lieu of formal qualification.
• At least 2 to 3 years experience in Quality Assurance or Regulatory Affairs, preferably in a similar Quality Engineering role within electronics manufacturing.
• Proficient in Microsoft Word, PowerPoint, and Excel.
• Capability to handle inquiries and complaints from internal customers and regulatory bodies.
• Experience in writing SOPs, training documentation, and regulatory responses.
• Preferred experience in Class III Medical Device Manufacturing environments.
• Six Sigma Green or Black Belt certification is advantageous.
• Experience with New Product Introduction processes is favorable.

Core Competencies

• Strong problem-solving skills using established techniques.
• Effective communication and influencing abilities.