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Qc Coordinator 2

2 months ago

Simpang Ampat, Malaysia Dexcom Full time

**Summary**

Assist with the day-to-day operations associated with Control of Nonconforming Materials. Assist management to ensure that products, procedures, and processes comply with applicable regulations and standards.

**Essential Duties and Responsibilities**
- Perform physically quarantine nonconforming material.
- Perform electronic inventory transactions to prevent unintended use.
- Execute activities per approved material disposition
- Facilitate NCMR processing in the electronic system
- Monitor NCMR trending, follow-up NCMR status, and reporting
- Maintain inventory under Quality Control through transactions and cycle counts.
- Assist with the identification and organization of quality records associated with Nonconforming Material with cross department personnel
- Support investigations into potential quality/compliance concerns.
- Support routine walk-through activities
- Perform other tasks as assigned to enable organizational and quality objectives to be met.

**Required Qualifications**
- Minimum 3 years working in the medical device, pharmaceutical, or other regulated industry in the Quality Assurance department.
- Understanding of Quality Management Systems (QMS) as applied to medical devices
- Proficiency with Microsoft Office, ERP System
- Ability to communicate effectively and clearly.
- Ability to work hands-on in a fast-paced environment
- Must be able to flex schedule to work in different shifts to support commercial run.

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