Quality Technician (12-Month Fixed Term Contract)

About the Role and Company

This full-time Quality Technician position is based at Sanmina's Fermoy, County Cork facility, specializing in manufacturing high-quality PCBAs, subassemblies, and complete Class III medical devices. The site holds FDA registration and ISO 13485:2016 certification, showcasing its commitment to medical device industry standards. The role supports the Quality Department and reports directly to the Quality Operations Lead. The position involves working twelve-hour shifts including day, night, and weekend duties, with competitive salary, shift allowances, and benefits.

Key Responsibilities

• Assist in defining, implementing, and improving quality procedures and processes.
• Perform in-process testing of products to ensure conformity.
• Complete weekly leak and burst tests to verify product sealing meets specifications.
• Verify Critical Process Parameters (CPPs) and conduct line clearance activities.
• Carry out internal process audits for Quality System compliance and effectiveness.
• Support audits by demonstrating testing requirements and best methods.
• Handle feedback and help improve customer-related Supplier Quality Issues.
• Participate in daily engagement meetings focused on quality processes.
• Identify potential improvements through quality reviews in areas such as yield, flow, documentation, and controls.
• Escalate quality concerns as needed and investigate non-conformances.
• Conduct weekly environmental sampling of ISO Class 8 cleanrooms.
• Prepare and review sterile release documentation, including endotoxin and bioburden test reports.
• Conduct and verify sterile product release activities.
• Support SMT line first-off verifications and line clearance confirmations.
• Review and approve unplanned maintenance on multiple assembly lines as required.
• Assess lot suitability for release by analyzing production logs, batch records, and specifications.
• Review and approve Design History Records (DHR) ensuring completeness and compliance.
• Operate Manufacturing Execution System (MES) and Oracle Agile daily to verify product assembly specifications are met.
• Ensure workspace compliance with site standards including ESD, MSD, housekeeping (5S), and safety protocols.
• Maintain adherence to quality standards and applicable regulatory requirements.
• Comply with Health & Safety legislation and regulations.

Performance Metrics

• Maintain yields at critical quality attribute stations.
• Ensure accuracy and consistency in record-keeping.
• Follow Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).
• Complete assigned tasks and projects aligned with performance goals.

Qualifications and Experience

• Essential: Minimum NFQ Level 6 certificate or diploma in Science or Engineering, or relevant equivalent experience.
• Good knowledge of problem-solving methodologies.
• Proficient with Microsoft Word, Excel, and PowerPoint.
• Strong communication and influential skills.
• Capable of drafting standard operating procedures and training materials.

Preferred Qualifications

• Previous experience in a quality role within the electronics manufacturing sector.
• Exposure to Medical Device Manufacturing environments.
• Certification in Six Sigma Green or Black Belt.
• Experience with New Product Introduction (NPI) processes.

Additional Information

• This is a shift-based role requiring 12-hour shifts including some nights and weekends.
• The facility provides a competitive base salary plus shift allowances and employee benefits.
• The working environment is focused on manufacturing automation supporting the product life cycle from prototyping to volume manufacturing.