QA Inspector 3 - Simpang Ampat, Malaysia - Dexcom

Dexcom
Dexcom
Verified Company
Simpang Ampat, Malaysia

1 month ago

Siti Tan

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Siti Tan

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Description

Summary:


As a member of the QA Lot Release team, the inspector is responsible to ensure 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:


  • Performing inprocess and final product review of documents for accurate format, signatures, dating and Good Documentation Practices (GMP) for commercial product in a timely matter
  • Maintain compliance with operating procedures and ensure training is completed prior to the operation of a task
  • Ensure all documentation is legible, complete, and correct per current Good Manufacturing Practices Inspect labeling for the finished product
  • Understand and perform line clearance activities in manufacturing
  • Perform inprocess quality audits in manufacturing to assure compliance to manufacturing documentation and good documentation practices
  • Initiate and assist with the NCMR process during manufacturing of commercial product
  • Demonstrate good computer skills and perform computer operations to generate reports and graphs using Microsoft Word and Excel
  • Perform inprocess product inspection and testing for commercial product
  • Must be able to distinguish between certain colors
  • Review shipping documentation to assure accurate order shipment
  • Provide training for new employees and shadow new hire during probation period
  • Takes on new challenges and expanding roles to assist with growing demands within different areas of the Quality Department
  • Responsible to support Lead / Supervisor overseen team as assigned
  • Able to work independently with mínimal supervision by Lead / Supervisor
  • Must have strong organization skills and attention to detail
  • Assumes and performs other duties as assigned.

Required Qualifications:


  • Typically requires a high school certificate (SPM) or Diploma in any field or equivalent with minimum 3 years of relevant industry experience and/or training
  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required
  • Experience using computer
  • Ability to understand and perform job per documents instructions in English
  • 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
  • Min 3 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
  • Able to communicate fluently in English is preferable

Education Requirements:


  • High school certificate (SPM) or Diploma in any field or equivalent

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