Quality Control Technician

About the role

Medical Device Industry

Tasks

• Conduct product testing, including testing supporting complaint investigations and stability verification
• Generate and maintain product testing results and reports
• Review production batch records / DHRs for accuracy and completeness
• Review finished goods batch records and identify/report deviations
• Ensure deviations are appropriately addressed and resolved before approval
• Perform spot-check inspections and audits of production operations
• Participate in the internal audit program
• Write, review, and approve Standard Operating Procedures (SOPs) as required
• Support Document Control, record retention, and sample retention activities
• Assist with returned instrument processing when required
• Log instruments returned from the field and maintain appropriate documentation
• Decontaminate returned instruments in a Biohazard Level II environment following established SOPs
• Inspect returned instruments for damage and perform basic investigations
• Document inspection and investigation results
• Prepare instrument documentation for repair facilities and package instruments as required

Requirements

• Quality Control / Quality Assurance experience in a medical device or regulated manufacturing environment
• Experience with DHRs, batch records, product testing, inspections, and deviations
• Knowledge of QMS, SOPs, internal audits, and document control
• Experience working in a GMP/regulated environment is highly preferred
• Strong documentation, analytic

Schedule

• 2:30 PM – 11:00 PM (2nd Shift)
• 12 Months

Location

• Atlanta, GA 30313