Dexcom Employment – Quality Assurance Analyst

Website Dexcom

Job Description:

Corrective and Preventive Action (CAPA) and Internal Audits. Assist management to ensure that products, procedures, processes, contracts and services comply with applicable federal and state rules and regulations; as well as internal standards.

Job Responsibilities:

  • Perform Internal Audits as Lead Auditor or member of the Audit Team. Participate in audit preparation, execution and audit reporting. Track completion of audit responses and verify effectiveness of actions taken.
  • Assist management with continuous improvement of processes and systems supporting the Company’s compliance functions.
  • Perform other tasks as assigned to enable organizational and quality objectives to be met.
  • Conduct investigations into potential quality / compliance concerns. Keep management informed of issues.
  • Stay current on applicable FDA, ISO and other applicable industry requirements. Monitor external publication sources for issues applicable to the Company.
  • Create or revise Standard Operating Procedures and Work Instructions governing the Company’s compliance functions.
  • Review nonconformance trending to identify need for corrective or preventive actions.
  • Review CAPA documentation for content and completion of required deliverables. Provide guidance as necessary to ensure appropriate depth of investigation and corrective and/or preventive actions. Assess effectiveness of corrective and preventive actions. Prepare CAPA Review Board meeting agenda and minutes.
  • Compile CAPA and Internal Audit performance metrics for review with management.
  • Perform duties of Recall Coordinator in association with the Company’s Corrections and Removals Policy.
  • Create training materials and execute training as necessary to communicate process requirements and provide guidance to user community.

Job Requirements:

  • Experience can substitute for degree requirements.
  • Good understanding of QMS as applied to medical devices.
  • Associate’s degree (A. A.) or equivalent from two-year college or technical school. Bachelor’s degree (B. A.) in science, engineering, quality or other technical field from a four-year college or university preferred.
  • Minimum 4 years of Quality Assurance or Compliance experience in the medical device and/or pharmaceutical industries.
  • Direct experience with Nonconforming Material, CAPA, and Internal Auditing preferred.

Job Details:

Company: Dexcom

Vacancy Type: Full Time

Job Location: Simpang Ampat, Penang, Malaysia

Application Deadline: N/A

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