Job Description

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Functional Description

Supports the organization with initial compliance and ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards for manufacturing and production. Performs evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards. Identifies risk and evaluates deficiencies while working with internal departments/business units to appropriately remedy them. Facilitates internal training on quality assurance requirements, processes, and procedures. May perform audits and risk assessments.

Summary

Key contributor to the administration of the following Dexcom compliance functions:

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.

Essential Duties and Responsibilities

• 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.
• Review nonconformance trending to identify need for corrective or preventive actions.
• 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.
• Compile CAPA and Internal Audit performance metrics for review with management.
• Perform duties of Recall Coordinator in association with the Company\xe2\x80\x99s Corrections and Removals Policy.
• Create or revise Standard Operating Procedures and Work Instructions governing the Company\xe2\x80\x99s compliance functions.
• Assist management with continuous improvement of processes and systems supporting the Company\xe2\x80\x99s 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.

• Direct experience with Nonconforming Material, CAPA, and Internal Auditing preferred.
• Good understanding of QMS as applied to medical devices.
• Experience can substitute for degree requirements.

• Associate\'s degree (A. A.) or equivalent from two-year college or technical school. Bachelor\xe2\x80\x99s degree (B. A.) in science, engineering, quality or other technical field from a four-year college or university preferred.
• Minimum 5 years of Quality Assurance or Compliance experience in the medical device and/or pharmaceutical industries.

Dexcom