Quality Technician III
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Job Location:
Newton, MA - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Department:
Job Summary
Description:
Equipment Qualification Technician III- Job Description
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.
Continuous Improvement:
* Identify opportunities to improve equipment qualification processes and implement best practices.
* Stay updated on changes to regulatory standards and industry advancements.
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.
Continuous Improvement:
* Identify opportunities to improve equipment qualification processes and implement best practices.
* Stay updated on changes to regulatory standards and industry advancements.
Qualifications:
Education:
* Associates or bachelors 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.
Disclaimer: The first 4-6 weeks of assignment will be training on the floor in shifts 7 AM to 7 PM. After training is complete assignment will be M-F: 8-5. However occasional overtime and after-hours support can be expected to make required progress of the project.
Education:
* Associates or bachelors 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.
Disclaimer: The first 4-6 weeks of assignment will be training on the floor in shifts 7 AM to 7 PM. After training is complete assignment will be M-F: 8-5. However occasional overtime and after-hours support can be expected to make required progress of the project.
Required Experience:
IC
Key Skills
- Quality Assurance
- Quality Inspection
- Calipers
- Coordinate Measuring Machine
- Food Industry
- GD&T
- ISO 9001
- Math
- Micrometer
- Quality Control
- HACCP
- Manufacturing
About Company
CCO is transforming consulting by prioritizing outcomes and rapid implementation.
