Quality Technician III
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Job Location:
Newton, MA - USA
Monthly Salary:
Not Disclosed
Posted on:
20 hours 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:
13 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:
13 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
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