Quality Control Technician

Candidates with experience in Quality Assurance, Quality Control, medical device manufacturing, DHR review, batch record review, GMP/GLP, product testing, SOP compliance, deviations, production inspections, internal audits, document control, complaint investigations, or regulated manufacturing are strongly encouraged to apply. This position will perform product testing, review production and batch documentation, support quality inspections, and audits, and ensure manufacturing activities are completed in accordance with established procedures and quality requirements.

The Fountain Group is a national staffing firm and we are currently seeking a Quality Control Technician for a prominent client of ours. This position is located in Atlanta, GA, 30313. Details of the position are as follows: 

Location: Atlanta, GA
Pay Rate: $26–$27/hour
Schedule: 2nd Shift | 2:30 PM–11:00 PM
Work Arrangement: Onsite

Position Overview

We are seeking a detail-oriented Quality Assurance Technician to support Quality Management System (QMS) activities within a regulated manufacturing environment. This position will perform product testing, review production and batch documentation, support quality inspections, and audits, and ensure manufacturing activities are completed in accordance with established procedures and quality requirements.

The ideal candidate will have previous Quality Assurance or Quality Control experience within the medical device, diagnostics, pharmaceutical, biotechnology, or another regulated manufacturing industry, with knowledge of GMP/GLP requirements and strong documentation skills.

Key Responsibilities

• Conduct product testing to support routine quality activities, complaint investigations, and stability verification.
• Generate and document product testing results and prepare associated reports.
• Review Device History Records (DHRs), production batch records, and finished goods records for accuracy, completeness, and compliance.
• Identify and report documentation discrepancies, deviations, and other quality issues.
• Ensure deviations and documentation issues are appropriately addressed and resolved prior to product approval or release.
• Review and approve intermediate products for continued use in manufacturing.
• Perform spot-check inspections and audits of production operations to verify compliance with approved procedures.
• Participate in the company's internal audit program.
• Write, review, revise, and approve Standard Operating Procedures (SOPs) as required.
• Support Quality Management System and documentation activities.
• Assist with Document Control, record retention, and sample retention activities as needed.
• Support returned product/instrument processing when required.
• Log returned instruments received from the field and maintain accurate documentation.
• Decontaminate returned instruments in a Biohazard Level II environment according to established SOPs.
• Inspect returned instruments for damage and perform basic investigations.
• Document inspection and investigation findings prior to secondary processing.
• Prepare documentation and package instruments for shipment to repair facilities when necessary.
• Maintain accurate and complete quality records in accordance with established procedures.
• Perform additional Quality Assurance activities as assigned.

Qualifications

• Bachelor's degree in a scientific or technical discipline preferred; an equivalent combination of education and relevant experience may be considered.
• At least 1 year of Quality Assurance or Quality Control experience preferred.
• Previous experience within the medical device industry strongly preferred.
• Experience working in a regulated manufacturing environment such as medical device, diagnostics, pharmaceutical, or biotechnology is highly desirable.
• Knowledge of Good Manufacturing Practices (GMP) and/or Good Laboratory Practices (GLP).
• Experience reviewing DHRs, batch records, production records, manufacturing documentation, or similar controlled records is highly preferred.
• Experience with product testing, inspections, quality documentation, deviations, internal audits, or complaint investigations is beneficial.
• Ability to read, understand, and follow SOPs, safety procedures, operating instructions, and technical documentation.
• Strong attention to detail with the ability to recognize deviations from approved manufacturing procedures.
• Ability to accurately document testing, inspection, and investigation results.
• Strong written and verbal communication skills.
• Proficiency with Microsoft Word, Excel, databases, inventory systems, and other computer-based documentation systems.
• Ability to work independently while collaborating effectively with Quality and Manufacturing teams.

Additional Requirements

• Must be comfortable working onsite on 2nd shift from 2:30 PM–11:00 PM.
• Must be comfortable working with returned instruments in a Biohazard Level II environment when required.
• Ability to use bleach and other approved cleaning agents for decontamination purposes.
• Ability to regularly sit and stand and occasionally walk throughout the workday.

Preferred Background

Candidates with experience in Quality Assurance, Quality Control, medical device manufacturing, DHR review, batch record review, GMP/GLP, product testing, SOP compliance, deviations, production inspections, internal audits, document control, complaint investigations, or regulated manufacturing are strongly encouraged to apply. 

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