QA Engineer 2 - Manufacturing

Dexcom Ireland - Athenry; Athenry; On-site; EUR 72,000 - 92,000; Full time

Benefits offered by this job

Growth opportunities on a global scale

In-house learning programs / tuition‑b

Tuition reimbursement

Job summary

Dexcom Ireland - Athenry is seeking a Quality Engineer II to support manufacturing operations, ensuring alignment with ISO 13485, FDA, and MDSAP requirements. Joanne Taylor, the Hiring Manager, will lead quality initiatives and cross‑functional collaboration across Operations, Manufacturing Engineering, and Quality teams.

The role emphasizes CAPA, change control, risk assessment, and continuous improvement, with multiple audits and documentation responsibilities to maintain compliance and

Qualifications

• Bachelor’s degree in engineering, quality, or a related field.
• At least 3 years of experience in a regulated industry.
• Experience with ISO 13485, 21 CFR Part 11, 21 CFR 820.
• Experience coordinating cross-site/global system projects and audits (FDA/BSI/MDSAP).

Responsibilities

• Lead quality engineering activities for manufacturing operations and CAPA processes.
• Analyze quality and manufacturing data to drive improvements.
• Support internal/external audits and regulatory compliance.
• Review drawings, specs, and inspection criteria for conformance.
• Mentor junior engineers and support training.
• Maintain quality system documentation and procedures.

Skills

Teamwork

Microsoft Office

Communication

Self-starter

Independent work

Education

Bachelor’s degree in engineering or related field

Tools

SQL (read-only)

MES/ERP/QMS systems

Job description

The Company

Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: to forever change how diabetes is managed and to unlock information and insights that drive better health outcomes. Now, 25 years later, we continue to pioneer and broaden our vision beyond diabetes to empower people to take control of their health through personalized, actionable insights that solve important health challenges. We remain committed to improving human health worldwide.

Job Title

Quality Engineer II

Hiring Manager

Joanne Taylor

Meet The Team

As a Quality Engineer, you will provide quality engineering support for manufacturing operations, ensuring products are produced in compliance with internal procedures, regulatory requirements, and customer expectations. You 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 collaboration with cross‑functional teams to maintain product quality and integrity. You may also assist in developing methods and procedures for quality assurance and control.

Essential Duties And Responsibilities

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

What Makes You Successful

• Minimum of 3 years of experience in a regulated industry or equivalent experience and training.
• Excellent teamwork skills and ability to work well in a team environment.
• Proficiency with Microsoft Office tools.
• Good oral and written communication skills.
• Self‑starter with the ability to identify improvement opportunities.
• Ability to work independently under limited supervision as well as in a team environment.

What You’ll Get

• A front‑row seat to life‑changing CGM technology. Learn about our brave Dexcom Warriors 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.
• An exciting and innovative, industry‑leading organization committed to employees, customers, and the communities we serve.

Travel Required

• 0–5%

Experience And Education Requirements

• Bachelor’s degree in engineering, quality, or a 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.

Equal Opportunity

Dexcom is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or veteran status. If you have a disability and need accommodation, contact Dexcom Human Resources at [e-mail].