Sr. Quality Assurance Engineer

Sr. Quality Assurance Engineer

Dexcom

Athenry, Ireland

Meet the Team

The Senior Quality Engineer at Dexcom Ireland provides experienced quality engineering support within a regulated medical device manufacturing environment, ensuring compliance with internal procedures, Good Manufacturing Practice (GMP), and applicable regulatory requirements.

The role supports manufacturing operations across manufacturing processes acting as the quality lead for assigned areas. Responsibilities include overseeing quality activities that support daily manufacturing, providing guidance on in‑process controls and environmental monitoring, leading investigations, and ensuring robust documentation and compliance practices. Working closely with Manufacturing, Engineering, Operations, and cross‑site Quality teams, the Senior Quality Engineer plays a key role in maintaining product quality, regulatory compliance, and driving continuous improvement across the site.

Where you come in

• You will have experience in Lot Release, sterilization and distribution processes
• You will review, update, and maintain existing quality management processes and procedures.
• You will work with cross-functional teams to initiate non-conformances/CAPAs and complete investigations as required.
• You will be responsible for planning, implementing, and managing compliance of manufacturing and lot release processes with internal and external safety, quality, and regulatory standards requirements for worldwide distribution.
• You will be involved in reviewing, implementing, and maintaining quality assurance protocols and methods for processing materials into partially finished or finished products.
• You will perform analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.
• You will participate in continuous improvement programs to enhance manufacturing, quality, safety, and training systems.
• You will monitor and report on quality metrics, such as defect rates and process capability.
• You will perform risk management activities (e.g., FMEA, risk assessments) to ensure the safety and effectiveness of products.
• You will lead risk management, validation, sample size, and external standards review and implementation activities.
• You will assure compliance with in-house and/or external specifications and standards (i.e., GLP, GMP, ISO Six Sigma).
• You will be involved in designing methods and procedures for inspecting, testing, and evaluating the precision and accuracy of production processes, production equipment, and finished products.
• You will have an understanding of the concepts, principles, and techniques of statistics and how to apply these to datasets, identifying patterns and drawing actionable insights.
• You will perform internal audits to ensure systems comply with requirements and are effective.
• You will communicate regularly with peers and management regarding activities, escalating issues or concerns as necessary.
• You will assume and perform other duties as assigned.

What makes you successful

• You have experience with CAPA, Non-Conformance, and problem-solving tools.
• You will have critical thinking, solid decision making and problem-solving skills.
• You will have strong written and oral communication and presentation skills.
• You will be proficient Microsoft Office and database applications (e.g. Excel and MiniTab or similar).
• QA experience in continuous improvement initiatives.
• Travel Required: 10% in the first year of employment, one trip to our sister sites.

Experience and Education Requirements:

• Typically requires a bachelor's degree in a technical discipline, and a minimum of 5-8 years related experience or master's degree and 2-5 years equivalent industry experience or a PhD and 0-2 years' experience.