QC Coordinator 2

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.