Quality Assurance Analyst 1
Dexcom, Inc

San Diego, California

Posted in Manufacturing and Production


This job has expired.

Job Info


About Dexcom

Founded in 1999, Dexcom, Inc. (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The company is the leader in transforming diabetes care and management by providing CGM technology to help patients and healthcare professionals better manage diabetes. Since the company's inception, Dexcom has focused on better outcomes for patients, caregivers, and clinicians by delivering solutions that are best in class - while empowering the community to take control of diabetes. Dexcom reported expected full-year 2021 revenues of $2.48B, a growth of 27% over 2020. Headquartered in San Diego, California, with additional offices in the Americas, Europe, and Asia Pacific, the company employs over 6,000 people worldwide.

Position Summary:

In this role the individual is a contributor aids in the administration of the Quality Management System 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 professional that has knowledge in Quality Management Systems with some experience in the application of Quality Assurance and Regulatory principles and policies, project management skills, or experience in other areas of the Quality systems such as Documentation Control, Training, Complaints, Quality Control, Quality Assurance, etc.

Essential Duties and Responsibilities:

  • Coordinate and assist with identification and organization of quality records associated with CAPA and Nonconforming Events.
  • Review Non-Conforming Event documentation for content and completion of procedural and regulatory requirements, as well as deliverables and overall administration of the Non-Conforming Event process. Provide guidance as necessary to ensure product impact is being assessed and corrections are completed.
  • 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.
  • Review nonconformance trending to identify need for corrective or preventive actions.
  • Aids in Manufacturing Walkthroughs in collaboration with Dexcom Audit Readiness guidance.
  • Work with Audit Team to support internal and external audits. Participate in audit preparation and execution.
  • Compile CAPA, NCE and Internal Audit performance metrics for review with management.
  • Asist in the creation or revision of Standard Operating Procedures and Work Instructions governing the Company's compliance functions.
  • Asist in the creation training materials and execute training as necessary to communicate process requirements and provide guidance to user community.
  • Assist management with continuous improvement of processes and systems supporting the Company's compliance functions.
  • 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:
  • Associate degree (A. A.) or equivalent from two-year college or technical school.
  • Minimum 1 year of quality or regulatory compliance experience in the medical device and/or pharmaceutical industries (other regulated industries may be considered).
  • Experience in Medical Device Industry can substitute for degree requirements.
  • 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.
  • Computer literate, and able to use software packages as Word, Excel, Outlook, PowerPoint Visio, or similar.
  • Collaborative, able to work effectively with diverse functional groups.
  • 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:
  • Bachelor's degree or equivalent experience specialized in quality, regulatory affairs and/or business administration preferred.
  • 1 to 2 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.
  • Quality System Analyst / Auditor certification desired.

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.

Functional/Business Knowledge

  • Learns to use professional concepts and skills.
  • Frequent use and general knowledge of industry practices, techniques, and standards. General application of concepts, and principles. Learns to use professional concepts and skills.
  • Applies company policies and procedures to resolve routine issues.

Scope

  • Works on problems of limited scope and complexity.
  • Works under only general supervision. Work is reviewed for soundness of judgment and overall accuracy. Receives general oversight and guidance on approaches for project related tasks.
  • Builds stable working relationships internally.

Judgement

  • Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained.
  • Normally receives detailed instructions on all work and work output it closely supervised.

Management

  • N/A

Field Sales

  • N/A

Experience and Education

  • Typically requires a Bachelors degree and 0-2 years previous experience.

Workplace Type

  • The Workplace Type for this role is Flex. Based on the nature of your position you will be working onsite approximately 2-3 days per week from collaborative space and hoteling desks at our Dexcom sites. You will need to be located within commuting distance (typically 75 miles/120km) of your assigned Dexcom site.

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 Dexcom Talent Acquisition at talentacquisition@dexcom.com.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom's AAP may be viewed upon request by contacting Talent Acquisition at talentacquisition@dexcom.com.

View the OFCCP's Pay Transparency Non Discrimination Provision at this link.


This job has expired.

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