Quality Technician

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:

• 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.
• Testing and Calibration:
• Conduct regular equipment testing and calibration to ensure proper functioning.
• Troubleshoot and resolve issues with equipment performance.
• 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.
• 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.
• 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.
• Identify opportunities to improve equipment qualification processes and implement best practices.
• Stay updated on changes to regulatory standards and industry advancements.

Qualifications:

• Associate's 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.
• 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.
• 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.