QA Engineering Technician 2

21 DexCom Malaysia Sdn Bhd; Penang; On-site; MYR 36,000 - 60,000; Full time

Job summary

Dexcom Malaysia in Penang seeks a Quality Technician to support QC/QA in a fast-paced manufacturing setting. You will handle nonconformance events, assist audits, and review quality documentation to ensure product integrity.

The role requires a Diploma or equivalent with 2–5 years of related experience, and familiarity with GMP/ISO standards is preferred. Proactive problem solving and attention to detail are essential.

Qualifications

• Diploma or equivalent and 2–5 years of related experience in quality control.
• Knowledge of FDA 21 CFR 820 and ISO 13485 is an advantage.
• Medical device experience preferred.
• Proficient in Microsoft Office applications.

Responsibilities

• Supports quality control and QA operations in a fast-paced manufacturing environment.
• Handles nonconformance events and related investigations (NCMR, excursions, etc.).
• Assists with audits and review of quality documentation.
• Maintains compliance with safety, quality, and regulatory standards.

Skills

Attention to detail

Microsoft Office

Education

Diploma or equivalent

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. 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.

Summary

We are seeking a quality technician who able to work in fast-paced environment. Performs functions associated with quality control and quality assurance operations and play a crucial role in ensuring the quality and compliance of our manufacturing processes is well maintained. 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

Supports quality engineering activities such as change order processing, nonconformance event processing and handling (Exp: NCMR, out of tolerance, excursion, etc), execution/ verification of validation protocols Collects data and conducts inspections in the manufacturing process from receiving inspection to product release to support investigations led by Quality Engineers. Support production through more presence on manufacturing line and support inspection team with questions related to methods or processes. May support Quality Engineering with compliance to in-house and/or external specifications and standards (i.e. GLP, GMP, ISO, Six Sigma). Update and maintain quality assurance protocols and methods for processing materials into partially finished or finished products. Responsible to ensure compliance of manufacturing and production processes with internal and external safety, quality, and regulatory standards requirements for worldwide distribution. Support and works on Nonconformance reports including work with cross functional team in nonconformance event assessment, QA verification, material disposition. Performs regular line audit to ensure systems comply with requirements and are effective. To provide assistance and support to the Quality Engineering and Operations function in day-to-day production quality issues and implement correction/ corrective action. Identify opportunities for process/ quality improvement and contribute to continuous improvement initiatives to enhance product quality/ process efficiency. Communicates any concerns about work process regarding environmental impact, health or safety issues to their manager. Able to reads and understands specifications and inspection criteria to apply criteria using appropriate and properly configured inspection tools. Able to reviews and interpret engineering drawing and specification. Decision making ability coupled with the ability to work on one's own initiative and with minimum supervision is required. May assist in training and mentoring junior technician. Applies intermediate computer skills in the use of Microsoft Office. Excellent attention to detail. Assumes and performs other duties as assigned.

Required Qualifications

Candidate must possess at least Diploma or equivalent and minimum 2-5 years of related experience. Proven experience in a quality control or related role within manufacturing environment are preferred. Medical Device experience preferred. Some knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO 13485 Quality management systems) will be added advantage. Adopts hand on approach and able to perform shift duties. Proficient in Microsoft office application knowledge.

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 Overview

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.