Dexcom-posted 3 months ago
$25 - $42/Yr
Full-time • Entry Level
Mesa, AZ
5,001-10,000 employees

In this role the individual is a contributor to the administration of the following Dexcom compliance functions: Performing Cycle Counts, daily inventory of MRB material and participating in monthly finance observations. Ensuring that product that does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. Process and evaluate Non-Conforming Events (NCE), Nonconforming Material Reports, 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 international standards. A professional that has knowledge in Manufacturing and Quality Management Systems with demonstrated experience in the application of Quality Assurance and Regulatory principles and policies, and project management skills.

  • Performing Cycle Counts, daily inventory of MRB material and participate in monthly finance observations.
  • Review nonconformance trending to identify need for corrective or preventive actions.
  • Review NCE and NCMR documentation for content and completion of required deliverables.
  • Provide guidance as necessary to ensure appropriate depth of investigation and action.
  • Perform Internal Audits as a member of the Audit Team.
  • Participate in audit preparation, execution.
  • Compile and provide input on performance metrics for review with management.
  • Create or revise Standard Operating Procedures and Work Instructions governing the Company’s compliance functions.
  • Assist management with continuous improvement of processes and systems supporting the Company’s compliance functions.
  • Stay current on applicable FDA, ISO and other applicable industry requirements.
  • Monitor external publication sources for issues applicable to the Company.
  • Create training materials and execute training as necessary to communicate process requirements and provide guidance to user community.
  • Conduct investigations into potential quality / compliance concerns.
  • Keep management informed of issues.
  • Perform other tasks as assigned to enable organizational and quality objectives to be met.
  • 1-2 years previous experience, Manufacturing and/or Quality.
  • Experience with Quality Management Systems, Cycle Counts, Nonconforming Material, Nonconforming Events.
  • Good understanding of QMS as applied to medical devices.
  • Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
  • Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
  • Collaborative, able to work effectively with diverse functional groups.
  • Experience can substitute for degree requirements.
  • Associate degree (A. A.) or equivalent from two-year college or technical school.
  • Bachelor’s degree or equivalent experience specialized in quality, regulatory affairs and/or business administration preferred.
  • Minimum 1-3 years of quality or regulatory compliance experience in the medical device and/or pharmaceutical industries (other regulated industries may be considered).
  • Quality System Auditor / Lead Auditor certification desired.
  • Salary: $25.72 - $42.83
  • Equal Opportunity Employer
  • Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
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