Staff Quality Assurance Analyst

Dexcom; Seberang Perai; On-site; MYR 100,000 - 150,000; Full time

Job summary

A leading medical technology company in Malaysia seeks a Staff Quality Analyst to enhance the Quality Management System through managing complaints and advanced data analysis. The ideal candidate will have a Bachelor's degree and 8-12 years of relevant experience, alongside knowledge of ISO 13485 and statistical tools like Minitab. This role offers growth opportunities in an innovative organization committed to improving lives through technology.

Benefits

Comprehensive benefits program

Growth opportunities

Career development access

Qualifications

• Strong knowledge of ISO 13485, 21 CFR 820, ISO 14971, and EU MDR.
• Proficiency in statistical analysis tools and advanced Excel functions.
• Familiarity with risk management and CAPA processes.
• Experience in Post-Market Surveillance and Field Action processes is preferred.

Responsibilities

• Log and process customer complaints complying with regulatory standards.
• Perform detailed investigations and root cause analysis.
• Ensure timely closure of complaints and maintain documentation accuracy.
• Support implementation of QMS processes to ensure compliance.

Skills

ISO 13485 knowledge

Statistical analysis

Communication skills

Problem-solving skills

Lean/Six Sigma certification

Education

Bachelor’s degree in Quality, Engineering, Sciences, Statistics

Tools

Minitab

Excel

Power BI

Job description

The Staff Quality Analyst plays a key role in supporting Quality Management System (QMS) enhancements, coordinating audits, managing customer complaints, and performing advanced data analysis to identify trends and drive continuous improvement.

Where you come in:

• You receive, log, and process customer complaints in compliance with regulatory standards.
• You perform detailed investigations, root cause analysis, and determine reportability where applicable (e.g., MDR, vigilance reporting).
• You ensure timely closure of complaints and maintain accurate documentation in complaint management systems.
• You ensure complaint handling aligns with PMS requirements and supports Field Action decision‑making.
• You assist in PMS activities, including data collection, trending, and risk evaluation.
• You support Field Action processes by providing complaint data analysis and risk assessment inputs.
• You lead and support investigations of internal quality issues through Nonconformance and Corrective and Preventive Action (CAPA) processes.
• You collaborate with cross‑functional teams to perform root cause analysis, develop effective corrective actions, and implement preventive measures to avoid recurrence.
• You ensure timely closure of Nonconformance and CAPA records while maintaining compliance with regulatory and QMS requirements.
• You monitor CAPA effectiveness and provide data‑driven insights for continuous improvement initiatives.
• You perform advanced statistical analysis on quality data (complaints, audit findings, CAPA metrics, PMS data).
• You use tools such as Minitab, Excel, or Power BI to identify trends, correlations, and predictive insights.
• You prepare dashboards and reports for management review and regulatory submissions.
• You support implementation and improvement of QMS processes to ensure compliance with ISO 13485, FDA QSR, and local regulatory requirements.
• You assist in process mapping, gap analysis, and documentation updates for efficiency and compliance.
• You plan, schedule, and coordinate internal audits and external inspections (regulatory and certification bodies).
• You prepare audit documentation, facilitate audit sessions, and track corrective actions to closure.
• You work closely with Quality, Regulatory, Operations, and Global teams to ensure alignment with QMS and PMS requirements.
• You provide training and guidance on complaint handling and data analysis best practices.

What makes you successful:

• You have strong knowledge of ISO 13485, 21 CFR 820, ISO 14971, and EU MDR; hands‑on audit hosting and inspection readiness
• You have proficiency in statistical analysis tools (e.g., Minitab, JMP, Excel advanced functions).
• You have excellent organizational, communication, and problem‑solving skills.
• You are familiar with risk management, CAPA processes, and customer complaint handling in a regulated medical device or pharmaceutical environment; this is preferred.
• You have experience in Post‑Market Surveillance (PMS) and Field Action processes; this will be considered an added advantage.
• You have Lean/Six Sigma or similar continuous improvement certification; this is preferred.
• You have professional certifications (e.g., ASQ CQE, CQA) – a plus.

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:

0‑25%

Experience and Education Requirements:

Typically requires a Bachelor’s degree in Quality, Engineering, Sciences, Statistics, or related field, and a minimum of 8‑12 years of related experience.