Quality Systems Specialist

American Society for Quality; Norcross (GA); On-site; USD 65,000 - 90,000; Full time

Job summary

GlobalMedLogistix in Norcross, GA is seeking a Quality Specialist to assist in maintaining the Quality Management System for medical device distribution. You will investigate NCRs, oversee QMS, review records, and ensure compliance with ISO 13485 and FDA requirements.

The role requires a Bachelor’s degree and 2–5 years of ISO 13485 QMS experience, with strong documentation, CAPA, and audit support skills. This is an on-site, full-time position in Norcross, GA.

Qualifications

• Bachelor's degree required.
• 2-5 years of experience in an ISO 13485-certified medical device QMS.
• Knowledge of ISO 13485:2016 and FDA regulations.
• Experience conducting NCR investigations.
• Experience with CAPA and root cause analysis.
• Experience supporting external audits and internal QA activities.

Responsibilities

• Conduct and document Nonconformance Reports (NCRs) and investigations.
• Prepare QC documentation: procedures, work instructions, forms, records.
• Develop and maintain SOPs, forms, and controlled quality documents.
• Review quality documents for ISO 13485 and FDA compliance.
• Support customer and regulatory audits and change control activities.
• Maintain document control and training records.
• Assist with training and training records.

Skills

Technical writing

MS Office

Quality systems

Education

Bachelor's degree

Tools

eQMS

Document Control systems

Change Control processes

Job description

Mission:

To be a trusted partner who drives better business results for our healthcare customers. Together we grow.

Position Overview:

The Quality Specialist assists in maintaining the Quality Management system of GlobalMed Logistix, a leader in medical device distribution. Daily tasks would include but are not limited to investigating nonconformances (NCRs), QMS oversight, pulling and reviewing records, scanning and filing training records, verifying training has been completed. Works closely with Operation Managers and Quality Manager to ensure day-to-day operations are performed to all Federal regulations, ISO standards, and internal procedures. Maintains rigorous quality mindset and advocates strict adherence to compliance practices within the facility.

Responsibilities

• Conducts and documents Nonconformance Reports (NCRs) and investigations.
• Prepares clear, concise, and technically accurate investigations, procedures, work instructions, forms, and quality documentation.
• Develops, revises, reviews, and maintains Standard Operating Procedures (SOPs), Work Instructions, Forms, and controlled quality documents.
• Reviews quality documentation for compliance with ISO 13485, FDA regulations, and customer requirements.
• Supports customer and regulatory audits.
• Supports Change Control activities.
• Maintains document control and quality records.
• Assists with employee training and training documentation.
• Participates in quality improvement initiatives.
• Works closely with Operations to improve processes while maintaining regulatory compliance.

Qualifications

• Bachelor's degree.
• 2-5 years of experience working within an ISO 13485-certified medical device Quality Management System.
• Demonstrated working knowledge of ISO 13485:2016 requirements and practical implementation.
• Experience conducting Nonconformance (NCR) investigations.
• Experience performing Root Cause Analysis and supporting CAPA activities.
• Experience writing and maintaining controlled quality documentation.
• Experience supporting external audits.
• Working knowledge of Document Control, Change Control, Training Systems, Quality Records, and Continuous Improvement.
• Strong technical writing skills.
• Proficient level with Microsoft Office (Outlook, Excel, PowerPoint).
• ASQ Certified Quality Auditor (CQA) or comparable certification preferred.
• ISO 13485 Internal Auditor or Lead Auditor training preferred.
• Experience supporting ISO 13485 certification audits preferred.
• Experience with electronic Quality Management Systems (eQMS) preferred.
• Must be legally authorized to work in the United States.
• Must be willing to submit to a pre-employment background check and drug screen.
• Must be at least 18 years of age.

Physical and Location Demands

While performing the duties of this job, the employee is regularly required to stand, walk, use hands to handle or feel, reach with hands and arms, stoop, kneel, and crouch. The employee is regularly required to sit and climb or balance and lift and/or move up to 50 pounds. The employee is regularly required to access and physically navigate the warehouse facility. This position is in Norcross, GA, on-site essential.

EEO

At GlobalMedLogistix, our people are the driving force behind everything we do. GlobalMedLogistix is an equal opportunity employer that aspires to be the best in the business by building a Team Member experience that celebrates growth, development, and purpose.

OTHER DUTIES

Please note: this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time, with or without notice.