Quality Support 2

1 DexCom Inc; Penang; On-site; MYR 48,000 - 72,000; Full time

Job summary

A leading company in continuous glucose monitoring, Dexcom, seeks a Quality Assurance professional in Penang. This role focuses on controlling nonconforming materials and ensuring compliance with regulations. With a strong emphasis on quality management systems, candidates should have relevant experience in regulated industries. Join a passionate team committed to transforming health outcomes through innovation.

Qualifications

• Minimum 3 years experience in the medical device or pharmaceutical industry.
• Understanding of Quality Management Systems (QMS) for medical devices.
• Ability to work in a fast-paced environment.

Responsibilities

• Perform quarantine of nonconforming materials.
• Monitor NCMR trending and reporting.
• Assist with quality record organization.

Skills

Quality Management Systems (QMS)

Microsoft Office

ERP System

Effective Communication

Hands-on Work

Job description

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

Assist with the day-to-day operations associated with Control of Nonconforming Materials. Assist management to ensure that products, procedures, and processes comply with applicable regulations and standards.

Essential Duties and Responsibilities

Perform physically quarantine nonconforming material.

Perform electronic inventory transactions to prevent unintended use.

Execute activities per approved material disposition

Facilitate NCMR processing in the electronic system

Monitor NCMR trending, follow-up NCMR status, and reporting

Maintain inventory under Quality Control through transactions and cycle counts.

Assist with the identification and organization of quality records associated with Nonconforming Material with cross department personnel

Support investigations into potential quality/compliance concerns.

Support routine walk-through activities

Perform other tasks as assigned to enable organizational and quality objectives to be met.

Required Qualifications

Minimum 3 years working in the medical device, pharmaceutical, or other regulated industry in the Quality Assurance department.

Understanding of Quality Management Systems (QMS) as applied to medical devices

Proficiency with Microsoft Office, ERP System

Ability to communicate effectively and clearly.

Ability to work hands-on in a fast-paced environment

Must be able to flex schedule to work in different shifts to support commercial run.

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.

WHY CHOOSE DEXCOM?

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.