Sr. Quality Assurance Engineer

Job Overview

Senior Quality Engineer at Dexcom Ireland provides experienced quality engineering support within a regulated medical device manufacturing environment, ensuring compliance with GMP and applicable regulatory requirements. The role supports manufacturing operations across processes, acting as the quality lead for assigned areas.

Responsibilities

• Oversee quality activities supporting daily manufacturing, including in-process controls, environmental monitoring, and documentation.
• Lead investigations and ensure robust documentation and compliance practices.
• Act as quality lead for assigned manufacturing areas and collaborate closely with Manufacturing, Engineering, Operations, and cross-site Quality teams.
• Plan, implement, and manage compliance of manufacturing and lot release processes with internal and external safety, quality, and regulatory standards for worldwide distribution.
• Review, update, and maintain existing quality management processes and procedures.
• Initiate non-conformances/CAPAs and complete investigations as required.
• Analyze reports and production data to identify trends and recommend updates or changes to quality standards and procedures.
• Participate in continuous improvement programs to enhance manufacturing, quality, safety, and training systems.
• Monitor and report on quality metrics such as defect rates and process capability.
• Perform risk management activities (e.g., FMEA, risk assessments) and lead risk management, validation, sample size, and external standards review.
• Ensure compliance with in-house and/or external specifications and standards (GLP, GMP, ISO Six Sigma).
• Design methods and procedures for inspecting, testing, and evaluating production processes, equipment, and finished products.
• Apply statistical techniques to datasets, identifying patterns and providing actionable insights.
• Conduct internal audits to ensure system compliance and effectiveness.
• Communicate regularly with peers and management regarding activities, escalating issues or concerns as necessary.

Qualifications

• Bachelor's degree in a technical discipline or equivalent experience.
• Typically 5-8 years of related experience, or a master's degree and 2-5 years of equivalent industry experience, or a PhD with 0-2 years.
• Experience with CAPA, non-conformance, and problem-solving tools.
• Strong critical thinking, decision-making, and problem-solving skills.
• Excellent written and oral communication and presentation skills.
• Proficiency with Microsoft Office and database applications (e.g., Excel and Minitab or similar).
• QA experience in continuous improvement initiatives.

Benefits

• A front-row seat to life-changing CGM technology.
• Opportunity to learn about our brave community.
• A full and comprehensive benefits program.
• Growth opportunities on a global scale.
• Access to career development through in-house learning programs and/or qualified tuition reimbursement.
• Travel Required: 10% in the first year of employment, one trip to sister sites.