QA Engineer 2 - Manufacturing

QA Engineer 2 - Manufacturing

Dexcom

Athenry, Ireland

Meet the team

As a Quality Engineer , you will provide quality engineering support for the manufacturing operations, ensuring products are manufactured in compliance with internal procedures, regulatory requirements, and customer expectations. The Quality Engineer II will partner closely with Operations, Manufacturing Engineering and Quality teams to drive product quality, process improvements, and operational excellence.

Where you come in

Acts as a key quality partner to manufacturing operations, ensuring products, processes, and quality systems remain compliant, effective, and inspection-ready while supporting continuous improvement and operational excellence. This position involves nonconformance event processing and analysis, internal/ external audit support, quality documentation review and processing, and collaborating with cross functional team to maintain product quality and integrity. May assist in developing methods and procedures for quality assurance and control.

Essential Duties and Responsibilities

• Leads and supports quality engineering activities including Change Orders, NCE and NCMR investigations, CAPA development and effectiveness verification, risk assessments, and validation activities for manufacturing operations.
• Collects, analyses, and interprets quality and manufacturing data to support investigations, drive process improvements, and ensure product quality.
• Utilises statistical methods and data analysis techniques to identify quality trends, investigate issues, and implement effective corrective and preventive actions.
• Analyses manufacturing and quality metrics to identify opportunities to improve yield, reduce defects, and enhance process capability.
• Acts as the primary Quality Engineering representative for assigned manufacturing areas, providing real-time support to production teams and facilitating timely resolution of quality issues.
• Partners with cross-functional teams including Operations, Manufacturing Engineering, Supply Chain, and Quality to support manufacturing objectives and drive continuous improvement initiatives.
• Ensures compliance with internal procedures, regulatory requirements, and applicable industry standards, including FDA, ISO 13485, and MDSAP requirements.
• Updates and maintains quality assurance procedures, inspection methods, and quality system documentation to ensure continued compliance and effectiveness.
• Supports qualification and validation activities, including protocol review, execution oversight, discrepancy resolution, and report approval, as applicable.
• Participates in risk management activities, including PFMEA reviews, control plan development, risk assessments, and implementation of risk mitigation strategies.
• Supports internal and external audits and inspection readiness activities, including FDA, ISO 13485, BSI, and MDSAP audits.
• Leads and supports nonconformance investigations, including event assessment, root cause analysis, QA verification, and material disposition activities.
• Performs regular manufacturing line audits to verify compliance, identify improvement opportunities, and ensure quality system effectiveness.
• Provides quality engineering support to manufacturing operations by addressing day-to-day production quality issues and implementing corrective and preventive actions.
• Identifies and drives process and quality improvement projects to enhance product quality, process efficiency, and operational performance.
• Reviews and interprets engineering drawings, specifications, procedures, and inspection criteria to ensure compliance with design and quality requirements.
• Applies appropriate inspection methods and properly configured measurement equipment to evaluate product and process conformance.
• Exercises sound judgment and decision-making skills while working independently and managing multiple priorities with minimal supervision.
• Assists in the training and mentoring of junior engineers, technicians, and cross-functional team members as required.
• Utilises Microsoft Office applications and quality systems effectively to support daily responsibilities.
• Communicates any concerns regarding product quality, compliance, environmental impact, health, or safety to management in a timely manner.
• Demonstrates strong attention to detail, organizational skills, and a commitment to operational excellence.
• Performs other duties as assigned.

What makes you successful

• Minimum of 3 years relevant experience
• Must work well in a team environment
• Proficient with microsoft office tools
• Strong communication skills
• Self-starter with the ability to identify improvement opportunities
• Able to work independently under limited supervision as well as in a team environment
• Travel Required: 0-5%

Experience and Education Requirements:

• Bachelor’s degree in engineering, Quality, or related field.
• At least 3 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. SQL experience for read only queries. Experience mentoring or training other engineers.