Quality Assurance Coordinator

JOB DESCRIPTION Quality Assurance Coordinator - 4880

Location: Fort Worth, TX

Position Summary:

The Quality Assurance Coordinator is responsible for supporting quality assurance activities within a regulated distribution environment. This position will assist with maintaining the Quality Management System (QMS), performing quality inspections, maintaining documentation, and ensuring compliance with applicable quality standards, including ISO 13485 and Good Manufacturing/Distribution Practices (GMP/GDP).

Essential Functions:

• Perform incoming, finished product, and other assigned quality inspections to ensure materials and products meet established requirements
• Support Quality Order and Return Material Authorization (RMA) processes, including inspection, documentation, and disposition of materials
• Generate and maintain Non-Conformance Material Reports (NCMRs) when quality issues or deviations are identified
• Maintain accurate quality records, procedures, work instructions, and other controlled documentation
• Support the maintenance and continuous improvement of the Quality Management System (QMS)
• Collaborate with cross-functional teams to investigate and address quality-related concerns
• Assist with monitoring temperature-controlled areas and applicable temperature monitoring systems
• Perform visual inspections, cycle counts, and other quality-related activities within the distribution environment
• Identify opportunities for process improvement and support implementation of quality system improvements
• Ensure assigned activities are completed accurately and in accordance with applicable quality and regulatory requirements
• Perform other quality-related duties as assigned

Qualifications:

• High school diploma or GED required
• 2+ years of Quality Assurance or related experience within the medical device, pharmaceutical, life sciences, or other regulated industry
• Experience working within a regulated Quality Management System preferred
• Knowledge of ISO 13485, GMP, GDP, and/or FDA-regulated environments preferred
• Quality or ISO 13485 certifications are a plus
• Experience with cold chain management or temperature monitoring systems is a plus

Skills and Abilities:

• Strong written and verbal communication skills
• Strong attention to detail and organizational skills
• Ability to review and interpret procedures, specifications, work instructions, and quality requirements
• Strong critical thinking and problem-solving skills
• Ability to effectively prioritize and manage multiple tasks in a fast-paced environment
• Proficiency with Microsoft Office; ERP system experience preferred
• Ability to work effectively with cross-functional teams
• Must be self-motivated and quality-focused

Work Environment:

• Warehouse, distribution, production, cleanroom, and office environments
• Position may require extended periods of sitting, standing, and walking throughout the workday
• Must be able to occasionally lift up to 35 pounds

Type of Assignment:

• Temp

Shift Schedule:

• Monday Friday day shift

Salary:

$30/hour + DOE

LS123

• Due to the high volume of applicants, only candidates who meet the requirements of the position will move through the interview process.
• This position does not offer C2C or H1-B sponsorship.
• Candidate acknowledges upon application that this position is not eligible for per diem or relocation reimbursement.