Quality Analyst 1

5 days ago

Penang, Malaysia Dexcom Full time

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 full-year 2022 revenues of $2.9B, a growth of 18% over 2021. Headquartered in San Diego, California, with additional offices in the Americas, Europe, and Asia Pacific, the company employs over 8,000 people worldwide.

**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**:

- Coordinate and facilitate internal and external audits to ensure compliance with regulatory requirements and standards in the medical industry.
- Drive the investigation, resolution, and documentation of non-conforming material reports (NCMR) and corrective and preventive actions (CAPA) to improve product quality and regulatory compliance.
- Perform data analysis on key quality metrics to identify trends, areas for improvement, and opportunities for optimization within the quality management system.
- Conduct routine walkthrough activities to assess adherence to quality procedures and processes, identifying areas for improvement and implementing corrective actions as necessary.
- Create training materials and act as a trainer for quality management system (QMS) training programs, ensuring employees understand and adhere to quality standards and procedures.
- Develop and implement quality awareness programs to enhance audit readiness and foster a culture of quality excellence throughout the organization.
- Stay updated on applicable FDA, ISO and relevant regulatory requirements, industry best practices, and emerging trends in the medical industry to ensure ongoing compliance and effectiveness of quality management processes.
- 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.
- Perform other tasks as assigned to enable organizational and quality objectives to be met.

**Required Qualifications**:

- Minimum of 2 years of experience in quality assurance or quality control roles within the medical industry, preferably in a regulated environment (e.g., FDA, ISO).
- Basic understanding of regulatory requirements and standards applicable to the medical industry, such as FDA regulations (e.g., 21 CFR Part 820), ISO 13485, and other relevant quality management systems.
- Experience coordinating and facilitating internal and external audits, including preparation, execution, and follow-up activities are preferable.
- Proficiency in analyzing and interpreting data related to quality metrics, with the ability to identify trends, root causes, and opportunities for improvement.
- Excellent communication, interpersonal, and presentation skills, with the ability to effectively train and educate employees at all levels of the organization.
- Proven ability to drive continuous improvement initiatives, implement corrective actions, and foster a culture of quality excellence.
- Detail-oriented with strong organizational and problem-solving skills, capable of managing multiple priorities and deadlines in a fast-paced environment.

**Education Requirements**:

- Bachelor's degree in a relevant field such as Quality Assurance, Biology, Chemistry, Engineering, mathematics or a related discipline.

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