QA Engineering Technician 2

Dexcom; George Town; In loco; MYR 42.000 - 54.000; Tempo pieno

Descrizione del lavoro

Dexcom Corporation in Malaysia is seeking a quality technician to operate in a fast-paced environment and assure quality control and QA across manufacturing processes. The role involves nonconformance handling, audits, document reviews, and collaboration with cross-functional teams to maintain product quality and integrity.

The position supports quality engineering and operations, performs inspections from receiving to release, and helps ensure compliance with safety and regulatory standards for

Competenze

• Diploma or equivalent with 2–5 years of related experience in quality control.
• Medical device experience and knowledge of FDA 21 CFR 820 and ISO 13485 is preferred.
• Willingness to perform shift duties and take a hands-on approach.

Mansioni

• Supports quality engineering activities such as change order processing and nonconformance handling.
• Collects data and conducts inspections from receiving to product release for investigations.
• Supports production on the manufacturing line and assists inspection teams.
• Ensures compliance with GLP, GMP, ISO, Six Sigma where applicable.
• Maintains QA protocols for materials into finished products.
• Ensures manufacturing and production meet safety, quality, and regulatory standards for global distribution.
• Assists with nonconformance reports and cross-functional assessments.
• Performs regular line audits to verify system effectiveness.
• Supports corrective actions in day-to-day production quality issues.
• Identifies opportunities for process and quality improvements.
• Communicates environmental, health, and safety concerns to management.
• Reads specifications and inspection criteria and applies them with proper tools.
• Reviews engineering drawings and specifications.
• Operates with initiative and minimal supervision; may train junior technicians.

Formazione

Diploma or equivalent

Strumenti

Microsoft Office

Descrizione del lavoro

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.

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.

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].