QA Engineering Technician 3 at Dexcom

Simpang Ampat, Penang, Malaysia -

Full Time

Start Date

Immediate

Expiry Date

14 Apr, 26

Salary

0.0

Posted On

14 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Control, Quality Assurance, Data Collection, Inspection, Compliance, Documentation Review, Nonconformance Handling, Process Improvement, Microsoft Office, Attention to Detail, Training, Auditing, Problem Solving, Team Collaboration, Regulatory Standards, Manufacturing Processes

Industry

Medical Equipment Manufacturing

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. Meet the team: 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. Where you come in: You support quality engineering activities such as change order processing, nonconformance event handling (e.g., NCMR, out of tolerance, excursion), and execution or verification of validation protocols. You collect data and conduct inspections throughout the manufacturing process, from receiving inspection to product release, to support investigations led by Quality Engineers. You support production by maintaining a strong presence on the manufacturing line and assisting the inspection team with questions related to methods or processes. You may support Quality Engineering in ensuring compliance with in-house and/or external specifications and standards (e.g., GLP, GMP, ISO, Six Sigma). You update and maintain quality assurance protocols and methods for processing materials into partially finished or finished products. You ensure compliance of manufacturing and production processes with internal and external safety, quality, and regulatory standards for worldwide distribution. You support and work on nonconformance reports, collaborating with cross-functional teams in event assessment, QA verification, and material disposition. You perform regular line audits to ensure systems comply with requirements and remain effective. You provide assistance and support to Quality Engineering and Operations in resolving day-to-day production quality issues and implementing corrective actions. You identify opportunities for process and quality improvement and contribute to continuous improvement initiatives to enhance product quality and process efficiency. You communicate any concerns about work processes regarding environmental impact, health, or safety issues to your manager. You read and understand specifications and inspection criteria, applying them using appropriate and properly configured inspection tools. You review and interpret engineering drawings and specifications. You demonstrate decision-making ability and work independently with minimal supervision. You may assist in training and mentoring junior technicians. You apply intermediate computer skills in the use of Microsoft Office. You maintain excellent attention to detail. You assume and perform other duties as assigned. What makes you successful: You must possess at least Diploma or equivalent and minimum 4-6 years of related experience. Proven experience in quality control or related role within manufacturing environment are preferred. You have 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. You adopt hands on approach and able to perform shift duties. Your proficiency in Microsoft office application knowledge. 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: (Highlight the appropriate range) 0-25% To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.

Responsibilities

The QA Engineering Technician 3 supports quality engineering activities, including nonconformance event handling and inspections throughout the manufacturing process. They collaborate with cross-functional teams to maintain product quality and compliance with safety and regulatory standards.