Sr Business Systems Analyst

21 DexCom Malaysia Sdn Bhd; Seberang Perai; On-site; MYR 180,000 - 240,000; Full time

Job summary

21 DexCom Malaysia Sdn Bhd, a global leader in CGM, seeks a Senior Validation Specialist to drive GxP validation across IT/OT for APAC operations. You will lead CSV, CSA, IQ/OQ/PQ, and related validation deliverables, while ensuring regulatory compliance.

You will partner with IT, OT, Quality and Manufacturing teams to shape validation strategies, risk assessments, and documentation across the SDLC, delivering auditable processes that support regulatory objectives.

Qualifications

• Bachelor's degree in Engineering, Quality, Computer Science, Life Sciences, or a related discipline.
• Minimum of 5 years of direct experience validating manufacturing systems and regulated computer systems.
• Proven experience validating enterprise systems such as MES, ERP, QMS, EDMS, LIMS, and manufacturing automation including PLC/SCADA.
• Strong understanding of GxP processes and FDA/ISO regulatory requirements.
• ASQ SQE certification and medical device experience desirable.

Responsibilities

• Serve as SME for validation and compliance of GxP systems (MES/ERP/QMS/SCADA/PLCs).
• Lead validation activities: CSV, CSA, IQ/OQ/PQ/PPQ, Test Scripts, and risk-based validation.
• Provide QA/QC guidance for IT/OT systems ensuring regulatory compliance and inspection readiness.
• Perform GxP risk assessments at system, functionality, and data-element levels.
• Advise IT/OT/Quality/Manufacturing on validation strategies and risk mitigation.
• Ensure compliance with FDA 21 CFR Part 11, ISO 13485, EU MDR and related regs.
• Develop and maintain validation deliverables across the SDLC.
• Communicate progress and risks to Dexcom teams and leadership.

Skills

Regulatory compliance

Validation leadership

Risk assessment

Quality systems

Cross-functional collaboration

Communication

Education

Bachelor's degree in Engineering/Quality/CS/Life Sciences

Tools

Microsoft Office

Excel

Minitab

Database applications

Job description

About the Company

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.

About the Role

Meet the team: Join our dynamic IT department at Dexcom, where innovation meets expertise in cost accounting within our Oracle EBS environment. As a crucial member of our team, you will be at the forefront of optimizing cost accounting processes, ensuring accuracy, efficiency, and compliance. With a supportive and collaborative atmosphere, you will have the opportunity to make a tangible impact on Dexcom's financial operations while working alongside talented professionals who share your passion for excellence. This position will involve supporting multiple APAC IT projects and may entail leading small projects as needed. Dexcom has regional teams in APAC, EMEA and US and this role will be functionally part of this wider team and will operate within its governance framework.

Responsibilities

• Serve as the Subject Matter Expert (SME) for validation and compliance of Enterprise and Manufacturing Systems, including MES/Camstar, ERP, QMS, SCADA, PLC, Data Historians, EBR, and other GxP-regulated platforms.
• Lead verification and validation activities, including Computer System Validation (CSV), Computer Software Assurance (CSA), Process Validation (IQ/OQ/PQ/PPQ), Test Method Validation, and Validation Master Planning.
• Provide QA and QC requirements, guidance, and oversight for IT and Operational Technology (OT) systems while ensuring regulatory compliance and inspection readiness.
• Perform GxP risk assessments at the system, functionality, and data-element levels, applying risk management principles, sample size determination, and external standards review.
• Serve as a core advisor to IT, OT, Quality, Manufacturing, and cross-functional teams by providing expertise on validation strategies, quality systems, compliance requirements, and risk mitigation.
• Ensure compliance with FDA 21 CFR Part 11, FDA 21 CFR 820, ISO 13485, EU MDR, and other applicable domestic and international regulations.
• Develop, execute, and maintain validation deliverables throughout the SDLC, including Validation Plans, Protocols, Risk Assessments, Traceability Matrices, Test Scripts, and Summary Reports.
• Effectively communicate project progress, validation status, compliance risks, and key challenges to broad Dexcom teams and senior leadership.
• Independently lead validation initiatives and project activities across cross-functional teams and projects of varying complexity.
• Design and continuously improve policies, procedures, and quality systems supporting validation, auditing, CAPA, calibration, training, document control, customer complaints, nonconforming materials, receiving inspection, and process controls.
• Apply Six Sigma, Total Quality Management (TQM), and continuous improvement methodologies to improve product safety, product consistency, compliance, operational efficiency, and cost performance.
• Interpret specifications and inspection criteria while utilizing Microsoft Office, Excel, MiniTab, and database applications to support quality, compliance, and business objectives.
• Perform additional duties and responsibilities as assigned in support of business and quality objectives.

Qualifications

• Bachelor's degree in Engineering, Quality, Computer Science, Life Sciences, or a related discipline.
• Minimum of 5 years of direct experience validating manufacturing systems and regulated computer systems within medical device, pharmaceutical, or other highly regulated industries.
• Proven experience validating enterprise systems such as MES, ERP, QMS, EDMS, Clinical Data Management Systems, LIMS, and manufacturing automation solutions including PLC, SCADA, Data Historians, and EBR.
• Strong understanding of GxP business processes, Quality Management Systems, FDA electronic records and electronic signature requirements, and computerized system validation expectations.
• Demonstrated expertise in FDA Computer Software Assurance (CSA), risk-based validation methodologies, and Computer System Validation (CSV) principles.
• Comprehensive knowledge of FDA 21 CFR Part 11, FDA 21 CFR 820, ISO 13485, EU MDR, and related regulatory requirements.
• Proven experience delivering full lifecycle CSV programs and maintaining compliance across both IT and OT environments, including 21 CFR Part 11 impacted systems.
• Hands‑on experience creating and executing Validation Plans, Protocols, Risk Assessments, Traceability Matrices, Test Scripts, and other validation documentation across all phases of the SDLC.
• Ability to independently manage projects, prioritize competing demands, and successfully lead cross-functional teams and stakeholders.
• Proven organizational skills and collaboration skills, with experience influencing teams and driving alignment across business and technical organizations.
• Excellent written and verbal communication skills, strong organizational and analytical capabilities, and exceptional attention to detail.
• ASQ Software Quality Engineer (SQE) certification, Medical Device industry experience, expertise in 21 CFR Part 11, and familiarity with 21 CFR 820 are highly desirable.

AI in Hiring Notice

We may use AI supported tools to help make our hiring process more efficient, consistent, and accessible for candidates around the world. All hiring decisions are made by people. At Dexcom, we are committed to providing a fair and inclusive recruitment process, and welcome candidates of all genders and gender identities to apply. If any wording in this description appears unintentionally gendered or exclusionary, please be assured this is not intentional. Should a reasonable accommodation be necessary to aid a disability, requests should be sent to Dexcom Talent Acquisition at [e-mail].

Company Mission

Since 1999, Dexcom has simplified and revolutionized diabetes management, positively impacting millions worldwide. At Dexcom, we're more than just a medical device company; we're a collective of visionary thinkers, trailblazers, and problem solvers. Our mission transcends the ordinary. We aim to revolutionize healthcare, one groundbreaking technology at a time.