Senior QA Engineer

Dexcom; George Town; On-site; MYR 236,000 - 336,000; Full time

Job summary

A global leader in diabetes management is seeking a Sr. Quality Engineer in George Town, Malaysia. The candidate will oversee compliance with manufacturing and production quality standards, design evaluation methods for processes, and perform internal audits to ensure ongoing quality. Ideal candidates will have a Bachelor’s degree and significant experience in the medical device industry, as well as proficiency in statistical tools. The role requires strong communication and planning skills, fostering teamwork in a fast-paced environment.

Qualifications

• 5-8 years of related experience or 2-5 years with a Master's degree.
• Medical Device experience preferred.
• Proficient in statistical tools is essential.
• Strong presentation and organizational skills required.

Responsibilities

• Plan and manage compliance with safety and quality standards.
• Design methods for inspecting and evaluating processes.
• Conduct internal audits and ensure compliance.
• Lead risk management and validation activities.

Skills

Strong communication skills

Statistical tools (Minitab, JMP)

Root cause analysis

Lean manufacturing techniques

Team collaboration

Education

Bachelor’s degree

Master’s degree

Tools

Microsoft Office

Power BI

MiniTab

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. To unlock information and insights that drive better health outcomes. We are 25 years later, having pioneered an industry, and we are 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, improving human health on a global scale.

Summary

We are seeking a Sr. Quality Engineer who can work in a fast‑paced environment. The candidate possesses advanced knowledge of technical principles and theories, applies company policies and procedures to resolve a variety of issues, works on problems of a more complex scope where analysis of situations or data requires a review of a variety of factors, exercises good judgment within defined procedures and practices to determine appropriate action, and builds productive internal/external working relationships.

Essential Duties And Responsibilities

• Responsible for planning, implementing and managing compliance of manufacturing and production processes with internal and external safety, quality, and regulatory standards requirements for worldwide distribution.
• Designs methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products.
• Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.
• May assure compliance to in‑house and/or external specifications and standards (i.e. GLP, GMP, ISO Six Sigma).
• Involved in review, implements and maintains quality assurance protocols and methods for processing materials into partially finished or finished products.
• Involved in designing methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products.
• May supervise and administer specific aspects of the quality system.
• Develops systems and performs quality functions that help Dexcom achieve its quality policy and compliance with domestic and international regulations. Some examples include Auditing, Calibrations, CAPA, Customer complaint processing, Document control, Nonconforming materials, Process controls, Receiving inspection, Training.
• Performs internal audits to ensure systems consistently comply with requirements and are effective, support external audits and drive closure of corrective actions.
• Participates as member of the design team. Activities may include assisting with defining design inputs; designing components and processes; verifying that design outputs satisfy design inputs.
• Leads risk management, validation, sample size, and external standards review and implementation activities.
• Employs techniques like Six Sigma, lean manufacturing and Total Quality Management to improve Dexcom operations.
• Improves systems and processes that improve product safety; increase product consistency and conformance to requirements; improve production efficiency; reduce operating and scrap costs.
• Coordinates the disposition of nonconforming materials with the Materials Review Board.
• Able to review and understand schematics and mechanical drawings. Reads, writes, and understands specifications and inspection criteria to apply criteria using appropriate and properly configured inspection tools.
• Assumes and performs other duties as assigned.

Required Qualifications

• Bachelor’s degree and minimum of 5-8 years of related experience; or Master’s degree and 2-5 years equivalent industry experience.
• Medical Device experience preferred. Knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO 13485) Quality management systems.
• Must have strong communication, presentation, organization, planning, and the interpersonal skills necessary to work as a team member and act as a liaison with customers.
• Applies proficient computer skills in the use of Microsoft Office and database applications (e.g. Excel, Power BI, MiniTab/JMP) is preferable.
• Proficiency with statistical tools (Minitab, JMP, or equivalent) and hands‑on experience in root cause analysis and corrective actions (8D, DMAIC).