Quality Control Technician

Select Source International; Atlanta (GA); On-site; USD 42,000 - 65,000; Full time

Job summary

Select Source International is seeking a Quality Control Technician in the Atlanta area to support the Quality Management System through testing, record review, and internal audits. The role involves reviewing device history Records and assisting in the documentation controls and instrument processing as needed.

The ideal candidate holds a scientific degree and has some QA/QC experience in medical devices, with strong attention to detail and ability to follow SOPs and regulatory requirements.

Qualifications

• Bachelor s degree in a scientific or technical discipline, or an equivalent combination of education and direct industry experience.
• Minimum of 1 year in a Quality Assurance or Quality Control role within the medical device industry is preferred.

Responsibilities

• Conduct routine product testing, including testing to support complaint investigations and stability verification.
• Generate accurate and timely product testing result reports.
• Review production Device History Records (DHRs) for accuracy and completeness to approve intermediate products for production. Review finished goods batch records.
• Identify and report all record deviations, ensuring they are fully addressed and resolved prior to issuing approvals.
• Conduct spot-check inspections/audits of production operations and actively participate in the internal audit program.
• Write, review, and approve Standard Operating Procedures (SOPs) as necessary.
• Assist in supporting Document Control, record retention, and sample retention programs.
• 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.

Skills

Mathematical concepts

Written & verbal communication

Process observation

Data/Office software

Bleach cleaning procedures

Education

Bachelor s degree in a scientific or technical discipline

Tools

Database software

Inventory software

Spreadsheet software

Word Processing software

Internet applications

Job description

Position Summary

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

Key Responsibilities

Core Quality & Testing Duties

• Conduct routine product testing, including testing to support complaint investigations and stability verification.
• Generate accurate and timely product testing result reports.
• Review production Device History Records (DHRs) for accuracy and completeness to approve intermediate products for production. Review finished goods batch records.
• Identify and report all record deviations, ensuring they are fully addressed and resolved prior to issuing approvals.
• Conduct spot-check inspections/audits of production operations and actively participate in the internal audit program.
• Write, review, and approve Standard Operating Procedures (SOPs) as necessary.
• 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.

Qualifications & Requirements

Education & Experience

• Bachelor s degree in a scientific or technical discipline, or an equivalent combination of education and direct industry experience.
• Minimum of 1 year in a Quality Assurance or Quality Control role within the medical device industry is preferred.

Skills & Competencies

• Ability to apply mathematical concepts (fractions, percentages, ratios, and proportions) to practical quality testing scenarios.
• Strong written and verbal communication skills. Ability to read/interpret safety rules, operating manuals, and standard procedures, and draft routine reports.
• Excellent process observation skills with the ability to understand manufacturing processes and recognize deviations from approved procedures.
• Hands-on experience with Database software, Inventory software, Spreadsheet software, Word Processing software, and Internet applications.
• Ability to use standard cleaning agents, including bleach, for cleaning and decontamination procedures.

Work Environment & Physical Demands

• None.
• Regularly required to sit and stand for extended periods; occasionally required to walk.