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QA Engineering Technician 2

Assist in maintaining compliance documentation for worldwide manufacturing standards
Penang, Malaysia
Junior
yesterday
DexCom

DexCom

A medical device company specializing in continuous glucose monitoring (CGM) systems for people with diabetes.

Quality Control And Quality Assurance Specialist

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. This position involves nonconformance event processing and analysis, internal/external audit support, quality documentation review and processing, and collaborating with cross-functional teams to maintain product quality and integrity. May assist in developing methods and procedures for quality assurance and control.

Essential duties and responsibilities (performance expectations vary by level):

  • Supports quality engineering activities such as change order processing, NCMR investigations, CAPA investigations, execution of validation protocols.
  • Collects data and conducts inspections in the manufacturing process from receiving inspection to product release to support investigations led by Quality Engineers.
  • Supports production through more presence on the manufacturing line and supports the inspection team with questions related to methods or processes.
  • May support Quality Engineering with compliance to in-house and/or external specifications and standards (i.e., GLP, GMP, ISO, Six Sigma).
  • Updates and maintains quality assurance protocols and methods for processing materials into partially finished or finished products.
  • Ensures compliance of manufacturing and production processes with internal and external safety, quality, and regulatory standards requirements for worldwide distribution.
  • Supports and works on Nonconformance reports including work with cross-functional teams in nonconformance event assessment, QA verification, material disposition, etc.
  • Performs regular line audit to ensure systems comply with requirements and are effective.
  • Provides assistance and support to the Quality Engineering and Operations function in day-to-day production quality issues and implements correction/corrective actions.
  • Identifies opportunities for process/quality improvement and contributes to continuous improvement initiatives to enhance product quality/process efficiency.
  • Communicates any concerns about work processes regarding environmental impact, health, or safety issues to their manager.
  • Able to read and understand specifications and inspection criteria to apply criteria using appropriate and properly configured inspection tools.
  • Able to review and interpret engineering drawings and specifications.
  • Decision-making ability coupled with the ability to work on one's own initiative and with moderate supervision is required.
  • Applies intermediate computer skills in the use of Microsoft Office.
  • Excellent attention to detail.
  • Assumes and performs other duties as assigned.

Experience and education requirements: Candidate must possess at least a diploma or equivalent and minimum 2-3 years of related experience. Proven experience in a quality control or related role within a manufacturing environment is preferred.

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QA Engineering Technician 2
Penang, Malaysia
Engineering
About DexCom
A medical device company specializing in continuous glucose monitoring (CGM) systems for people with diabetes.