Quality Technician III

Position Summary: An Equipment Qualification Technician is responsible for ensuring that equipment used in manufacturing, laboratory, or other operational environments meets required standards of functionality, reliability, and compliance. They play a key role in validating and qualifying equipment to ensure it operates according to established specifications and regulatory requirements.

Key Responsibilities:

1. Equipment Qualification:
   • Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for new and existing equipment.
   • Ensure equipment meets regulatory standards (e.g., FDA, ISO, GMP, etc.) and internal quality requirements.
   • Document and report qualification results, including deviations and corrective actions.
   • Hands-on activities to troubleshoot and resolve technical issues with newly installed equipment.
   • Brainstorming with subject matter experts (SME) to do Root Cause Analysis (RCA).
   • Utilize standard process improvement methodologies such as FMEA, Six Sigma, DOE, Hypothesis Tree, DMAIC, Fishbone Diagram.
   • Work with trained operators to learn how to setup equipment and be trainer to train others.
2. Testing and Calibration:
   • Conduct regular equipment testing and calibration to ensure proper functioning.
   • Troubleshoot and resolve issues with equipment performance.
3. Documentation and Reporting:
   • Prepare detailed reports documenting qualification processes, outcomes, and compliance.
   • Maintain accurate and up-to-date records of all equipment qualifications and calibrations.
4. Compliance and Regulatory Standards:
   • Ensure adherence to regulatory and industry standards such as Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), ISO standards, or other applicable guidelines.
   • Assist in audits and inspections as needed.
5. Equipment Maintenance and Support:
   • Collaborate with engineering, maintenance, and quality teams to ensure proper equipment care and operation.
   • Provide training and technical support to staff using qualified equipment.

6. Continuous Improvement:
   • Identify opportunities to improve equipment qualification processes and implement best practices.
   • Stay updated on changes to regulatory standards and industry advancements.

7. 
   
   • Associate or bachelor's degree in engineering, science, or a related technical field. Relevant certifications may be considered.

Experience: 1–3 years of experience in equipment qualification or a related role.

Technical Skills:

• 
  
  • Knowledge of equipment qualification protocols (IQ, OQ, PQ).
  • Familiarity with regulatory requirements (e.g., ISO, OSHA).
  • Proficiency with diagnostic tools and calibration equipment.
  • Industrial equipment operation and troubleshooting.
• Soft Skills:
  • Strong analytical and problem-solving skills.
  • Excellent written and verbal communication.
  • Attention to detail and ability to follow procedures precisely.
• Other Requirements:
  • Ability to work independently and as part of a team.
  • Willingness to travel to different sites when necessary.
  • Physical ability to handle equipment and perform inspections.

Work Environment:

• May involve working in laboratories, manufacturing facilities, or cleanroom environments.
• Requires adherence to safety protocols and use of personal protective equipment (PPE) as needed.

This role is critical for ensuring equipment reliability and regulatory compliance, supporting the success and integrity of operational processes.