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. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health.
We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.
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
What you’ll get:
- A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors 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 our employees, customers, and the communities we serve.
Travel Required:
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.
To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.
#DexcomIreland
