Senior Quality Assurance Analyst Details

Senior Quality Assurance Analyst

Dexcom - San Diego, CA

Employment Type : Full-Time

About Dexcom:

Dexcom, Inc. empowers people to take control of diabetes through innovative continuous glucose monitoring (CGM) systems. Headquartered in San Diego, California, Dexcom has emerged as a leader of diabetes care technology. By listening to the needs of users, caregivers, and providers, Dexcom simplifies and improves diabetes management around the world.

Summary:

Key contributor to the administration of the following DexCom compliance functions: Corrective and Preventive Action (CAPA), 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 seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways. Demonstrates further technical development and a track record of project success. Demonstrates an ability to coordinate multiple projects simultaneously. Considered a specialist in the field within the function.

Essential Duties & 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’s Corrections and Removals Policy.
• 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.

Required Qualifications:

• Direct experience with Quality Management Systems, Nonconforming Material, Nonconforming Events, CAPA, and Internal Auditing.
• 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.
• 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.

Preferred Qualifications:

• Minimum 5 years of quality or regulatory compliance experience in the medical device and/or pharmaceutical industries (other regulated industries may be considered).
• Or equivalent combination of education and experience.
• Previous use of Reliance electronic quality management system or equivalent.
• Quality System Auditor / Lead Auditor certification desired.

Experience and Education Requirements:

• Typically requires a Bachelor’s degree and a minimum of 5 – 8 years of related experience.

Travel Required:

• Up to 25%

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An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Talent Acquisition at talentacquisition@dexcom.com.

To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.