Quality Technician 3 Back End Nights

Position Overview

We have exciting opportunities for Quality Technician 3's on a permanent non rotational night shift (Friday to Sunday, alternating Thursdays 7pm to 7am). The role is part of Dexcom Ireland's regulated medical device manufacturing team, ensuring compliance with GMP, GLP, ISO, and FDA requirements.

This schedule offers 14 out of 28 days of work per month, 12 hour shifts with paid breaks, allowing ample time for family, education, and personal well being.

Key Responsibilities

• Support Quality Engineering activities, including change order processing, nonconformance events (NCEs), nonconforming material reports (NCMRs), and CAPA investigations.
• Collect manufacturing and inspection data and perform inspections to support investigations led by Quality Engineers.
• Provide daily presence on the manufacturing floor and assist the inspection team with questions related to inspection methods, processes, and specifications.
• Maintain compliance with internal procedures and external standards, including GMP, GLP, ISO, and Six Sigma.
• Update and maintain quality assurance procedures, protocols, and methods for processing materials into partially finished and finished products.
• Ensure manufacturing and production processes comply with internal quality systems and applicable safety, quality, and regulatory requirements.
• Support investigation, assessment, verification, and disposition of nonconforming materials with cross functional teams.
• Perform routine line audits to verify that systems are compliant, effective, and operating as intended.
• Address production quality issues and support corrective action implementation.
• Identify opportunities for quality and process improvement and contribute to continuous improvement initiatives.
• Communicate concerns related to work processes, environmental impact, health, or safety in a timely manner.
• Read and interpret specifications, inspection criteria, and engineering drawings, applying requirements using appropriate inspection tools.
• Demonstrate sound decision making skills and ability to work independently with minimal supervision.
• Assist in training and mentoring of junior technicians when required.
• Apply intermediate computer skills, including Microsoft Office applications.
• Demonstrate excellent attention to detail and strong documentation practices.

Qualifications

• 2-4 years of experience in a medical device or similarly regulated manufacturing environment, applying quality systems with confidence and consistency.
• Strong shop floor presence and ownership of assigned quality systems, proactively engaging with Operations to support compliance and real time issue resolution.
• Active contribution to nonconformance investigations and CAPA activities through timely assessment, effective collaboration, and thorough documentation.
• Audit ready behaviours with a clear understanding of FDA, ISO, and MDSAP requirements; ability to support inspections and audits confidently.
• Sound judgement and confident decision making, taking ownership of issues while knowing when and how to escalat your concern appropriately.
• Effective independent and collaborative work with minimal supervision.

Benefits

• Front row seat to continuous glucose monitoring technology and the opportunity to make a meaningful impact for our global community.
• Competitive and comprehensive benefits package to support health, wellbeing, and financial security.
• Career growth opportunities on a global scale within a rapidly growing and innovative organization.
• Ongoing career development, including in house learning programs and qualified tuition reimbursement.
• Opportunity to work with an industry leading organisation committed to employees, customers, and the communities it serves.

Experience and Education Requirements

• Level 6 in Quality or a related discipline.
• Minimum of 2 years of experience in a regulated industry.
• Knowledge of ISO 13485, 21 CFR Part 11, 21 CFR 820.
• Experience working on cross site or global system projects.
• Audit experience with FDA, BSI, or MDSAP.
• Experience with manufacturing systems, MES, ERP, or QMS applications.