QA Engineer 2

QA Engineer 2

Dexcom

Athenry, Ireland

As a QA Engineer, you will play an integral role in ensuring the quality of site processes in Lot Release in compliance with Dexcom procedures. This crucial position supports Dexcom's exciting growth trajectory in delivering essential, life-changing products to our customers. As part of this dynamic and highly effective team, you will work closely across multiple functions, gaining broad exposure to our entire product life cycle.

Where you come in:

• Coordinate and actively participate in the quality assurance of site processes and the Lot Release function in compliance with Dexcom procedures.
• Establish the lot release process in collaboration with other Dexcom sites, sterilization partners, and distribution companies.
• Ensure lot release activities remain on track, proactively resolving issues and serving as the responsible owner for related NCRs and CAPAs.
• Work with internal and external cross‑functional teams to design, implement, and maintain compliant lot release processes, while continuously identifying opportunities for process improvement.
• Update and maintain documentation to ensure accuracy, compliance, and alignment with evolving processes and standards.
• Review quality documents to ensure they meet cGMP standards.
• Manage investigations and implement corrective actions as needed.
• Participate in continuous improvement programs to enhance manufacturing, quality, safety, and training systems.
• Review, update, and maintain existing quality management processes and procedures.
• Perform risk management activities (e.g., FMEA, risk assessments) to ensure product safety and effectiveness.
• Plan, implement, and manage compliance of manufacturing and production processes with internal and external safety, quality, and regulatory standards for worldwide distribution.
• Monitor and report on quality metrics, such as defect rates and process capability.
• Perform other duties as assigned.

What makes you successful:

• Typically requires a Bachelor’s degree in a technical discipline and 2–5 years of related experience, or a Master’s degree and 0–2 years of equivalent experience.
• Quality experience in a medical device or related industry manufacturing environment.
• Experience with CAPA, Non-Conformance, and problem-solving tools.
• Participation in continuous improvement initiatives.
• Proficiency in Microsoft Office and database applications (e.g., Excel and MiniTab or similar).
• Strong critical thinking, decision-making, and problem-solving skills.
• Excellent written and oral communication and presentation skills.