QA Engineer 2

Dexcom; George Town; On-site; MYR 40,000 - 80,000; Full time

Job summary

Ein innovatives Unternehmen sucht einen Qualitätsmanager, der sich auf die Entwicklung und Implementierung von Qualitätsmanagementprotokollen konzentriert. Diese Rolle erfordert die Analyse von Daten zur Identifizierung von Trends und die Sicherstellung der Einhaltung von regulatorischen Standards. Der erfolgreiche Kandidat wird Teil eines dynamischen Teams sein, das sich leidenschaftlich für die Verbesserung der Gesundheitsversorgung einsetzt. Wenn Sie eine Leidenschaft für Qualitätssicherung haben und in einem zukunftsorientierten Umfeld arbeiten möchten, ist diese Position ideal für Sie.

Qualifications

• Mindestens 2 Jahre Erfahrung im Qualitätsmanagement oder medizinischen Geräten.
• Bachelorabschluss oder fortgeschrittener Abschluss ohne Erfahrung.

Responsibilities

• Entwicklung und Implementierung von Qualitätsmanagementprotokollen.
• Überwachung der Einhaltung von Sicherheits- und Qualitätsstandards.

Skills

Qualitätsmanagement

Six Sigma

Lean Manufacturing

TQM

Datenanalyse

Microsoft Office

Education

Bachelorabschluss

Fortgeschrittener Abschluss

Tools

Datenbankanwendungen

Job description

Company Overview

Dexcom Corporation (NASDAQ: DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Founded with the mission to transform diabetes management, Dexcom has been at the forefront of the industry for 25 years, now expanding its vision to empower individuals with personalized health insights to address broader health challenges. Our goal is to continue improving human health by developing innovative biosensing technologies.

Our team comprises passionate and ambitious professionals committed to earning customer trust through integrity, service, and innovation. We aim to become a leading consumer health technology company, continuously reinventing health solutions and expanding our impact globally.

Position Summary

The role involves developing professional expertise, applying company policies to resolve issues, analyzing situations or data, and exercising judgment within established procedures. Building effective internal and external relationships is essential.

Key Responsibilities

1. Design, implement, and maintain quality assurance protocols for processing materials into finished products.
2. Plan, implement, and manage compliance of manufacturing processes with safety, quality, and regulatory standards for global distribution.
3. Develop methods for inspecting, testing, and evaluating production processes and products.
4. Analyze reports and data to identify trends and recommend updates to quality standards.
5. Ensure compliance with standards such as GLP, GMP, ISO, Six Sigma.
6. Lead quality system audits, calibrations, CAPA, customer complaint processing, document control, and other quality functions.
7. Participate in design reviews, risk management, validation, and standards review activities.
8. Utilize techniques like Six Sigma, lean manufacturing, and TQM to enhance operations.
9. Improve systems to enhance product safety, consistency, efficiency, and reduce costs.
10. Coordinate disposition of nonconforming materials.
11. Review specifications and schematics, and apply inspection criteria with proper tools.
12. Maintain proficient computer skills, especially in Microsoft Office and database applications.
13. Perform other duties as assigned.

Experience and Education

• Bachelor’s degree with at least 2 years of related experience, or an advanced degree without experience, or equivalent combination.
• Medical device experience is preferred.

Note: Our careers site is for individuals seeking employment at Dexcom. Only authorized staffing agencies may submit profiles or resumes. Dexcom does not accept unsolicited resumes and is not responsible for related fees.