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QA Inspector 2

QA Inspector 2

DexcomGeorge Town, Penang, Malaysia
2 days ago
Job description

Company Overview

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.

Job Summary

As a member of the QA Lot Release team, the inspector is responsible for ensuring the activities related to the inspection functions in a manner which meets company standards and methods as determined by quality assurance or other engineering departments.

Essential Duties And Responsibilities

  • Performs in-process and final product review of documents for accurate format, signatures, dating, and Good Documentation Practices (GMP) for commercial product in a timely manner.
  • Performs in-process product inspection and testing for commercial product as conforming to specified requirements in accordance with product specification and quality assurance standards.
  • Prepares, records, and updates inspection report form.
  • Maintains compliance with operating procedures and ensures training is completed prior to the operation of a task.
  • Ensures all documentation is legible, complete, and correct per current Good Manufacturing Practices. Inspects labeling for the finished product.
  • Applies approval or rejection labels to lot / product once inspection data is completed and the review of lot history record (LHR) is done.
  • Initiates and assists with the NCMR process during manufacturing of commercial product.
  • Demonstrates good computer skills and performs computer operations to generate reports and graphs using Microsoft Word and Excel.
  • Reviews shipping documentation to assure accurate order shipment.
  • Is responsible for regular inspection report compilation and update.
  • Monitors equipment and instrumentation to ensure it is clean and safe to use.
  • Uses the Microsoft Suite of products : Word, Excel, Outlook.
  • Adheres to all GMP, safety guidelines, and company standards at all times.
  • Assumes and performs other duties as assigned.

Required Qualifications

  • Typically requires a high school certificate (SPM), or a related field with a minimum of 2 years of relevant industry experience and / or training.
  • Good interpersonal and teamwork skills.
  • Must be able to flex schedule to work in different shifts to meet demand.
  • Preferred Qualifications

  • Quality Assurance and / or QA / QC experience.
  • Minimum 2 years in the medical device industry or manufacturing industry previous experience.
  • Ideally has experience working with the following : Cloud PLM, Oracle, and / or Camstar software programs.
  • Education Requirements

  • High school certificate (SPM) in any field or equivalent.
  • Dexcom is an Equal Opportunity Employer.

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    Qa Inspector • George Town, Penang, Malaysia

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