Quality Control Technician

Location: Atlanta, GA 30313 • Duration: 12 Months

About the Role

The Quality Control Technician performs a wide variety of activities to support the Quality Management System (QMS), including product testing, record review, internal audits, and ensuring compliance with regulatory and quality standards throughout the production lifecycle.

Responsibilities

• Product Testing: Conduct routine product testing, including testing to support complaint investigations and stability verification.
• Reporting: Generate accurate and timely product testing result reports.
• Batch Record Review: Review production Device History Records (DHRs) for accuracy and completeness to approve intermediate products for production. Review finished goods batch records.
• Deviation Management: Identify and report all record deviations, ensuring they are fully addressed and resolved prior to issuing approvals.
• Audits & Inspections: Conduct spot-check inspections/audits of production operations and actively participate in the internal audit program.
• Documentation: Write, review, and approve Standard Operating Procedures (SOPs) as necessary.
• System Support: Assist in supporting Document Control, record retention, and sample retention programs.
• Returned Instrument Processing (As Needed):
  • Log returned instruments received from the field.
  • Decontaminate returned instruments in a Biohazard Level II environment following established SOPs and documentation requirements.
  • Inspect returned instruments for damage, perform basic initial investigations, and document results prior to second-level processing.
  • Process instrument documentation for return to repair facilities and pack instruments according to guidelines.

Requirements

• Education: Bachelor’s degree in a scientific or technical discipline, or an equivalent combination of education and direct industry experience.
• Experience: Minimum of 1 year in a Quality Assurance or Quality Control role within the medical device industry is preferred.
• Compliance: Demonstrated ability to follow Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
• Technical & Mathematical: Ability to apply mathematical concepts (fractions, percentages, ratios, and proportions) to practical quality testing scenarios.
• Communication: Strong written and verbal communication skills. Ability to read/interpret safety rules, operating manuals, and standard procedures, and draft routine reports.
• Attention to Detail: Excellent process observation skills with the ability to understand manufacturing processes and recognize deviations from approved procedures.
• Software Proficiency: Hands-on experience with Database software, Inventory software, Spreadsheet software, Word Processing software, and Internet applications.
• Special Requirements: Ability to use standard cleaning agents, including bleach, for cleaning and decontamination procedures.

Work Environment & Physical Demands

• Supervisory Responsibilities: None.
• Physical Demands: Regularly required to sit and stand for extended periods; occasionally required to walk.
• Work Environment: Includes standard office/lab settings and potential exposure to a Biohazard Level II environment for instrument decontamination. The noise level is typically quiet.