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Responsibilities:
- Leads and Coordinates and ensures compliance to CAPA, HHA and NCE systems.
- Provide guidance as necessary to ensure appropriate depth of investigation and corrective and/or preventive actions.
- Assess effectiveness of corrective and preventive actions.
Requirements:
- Direct experience with Quality Management Systems, Nonconforming Material, CAPA, HHA/HHE, Nonconforming Events, Internal and External Audits.
- Experience in FDA audits
- Good understanding of QMS as applied to medical devices.
Day-to-day:
- Can work well alone, normally receives little instruction on day-to-day work, general instructions on new assignments.
- A positive attitude is important while working in a fast-paced environment and dealing with shifting priorities.
- Assumes and performs other duties as assigned.
Dexcom Corporation
Dexcom Corporation is a pioneer and global leader in continuous glucose monitoring (CGM) and is broadening its vision beyond diabetes to empower people to take control of their health. Thousands of ambitious, passionate people worldwide are willing to fight like warriors to earn the trust of our customers.