QC Coordinator 2

Dexcom; Seberang Perai; On-site; MYR 30,000 - 60,000; Full time

Job summary

An established industry player is seeking a dedicated Quality Assurance professional to support the control of nonconforming materials. In this role, you will assist in maintaining compliance with regulations and standards while performing essential duties such as quarantining nonconforming materials, executing inventory transactions, and facilitating NCMR processing. Your expertise in Quality Management Systems and hands-on approach in a fast-paced environment will be crucial. Join a team that values quality and compliance, and contribute to the success of innovative medical device solutions.

Qualifications

• 3+ years in Quality Assurance within regulated industries.
• Understanding of Quality Management Systems for medical devices.

Responsibilities

• Quarantine nonconforming materials and perform inventory transactions.
• Monitor NCMR trends and assist with quality records organization.

Skills

Effective Communication

Hands-on Work

Flexibility in Scheduling

Tools

Microsoft Office

ERP System

Job description

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 and 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.