Hardy Process Solutions
Quality Management and Documentation Control Technician
Hardy Process Solutions, San Diego, California, United States, 92189
Quality Management and Documentation Control Technician
The Quality & Compliance Specialist ensures that all organizational processes, products, and systems comply with internal standards and external regulations. This role supports quality assurance initiatives, monitors compliance with regulatory requirements, leads/manages audits, and drives continuous improvement across departments. In addition, you will support the Quality Management System (QMS), documentation control, and compliance activities, strengthening our overall operational excellence and regulatory readiness.
Job Summary:
The Quality & Compliance Specialist ensures that all organizational processes, products, and systems comply with internal standards and external regulations.
Key Responsibilities
Quality Management
Control and improve the Quality Management System (QMS) in accordance with ISO 9001:2015.
Conduct internal audits and lead corrective/preventive action (CAPA) initiatives.
Coordinate root cause analysis and continuous improvement activities.
Develop and implement quality improvement initiatives to enhance operational performance and customer satisfaction.
Ensure quality control metrics are tracked, reported, and acted upon.
Compliance
Champion adherence to industry standards and regulatory requirements (e.g., ISO, UL, NTEP, CE, REACH, RoHS, etc.).
Maintain required certifications and lead the organization’s preparation for external audits, inspections, and customer assessments.
Partner with internal teams and external stakeholders to support regulatory submissions, customer audits, and third-party certification processes.
Stay ahead of evolving laws, standards, and industry requirements, proactively integrating updates into company practices and policies.
Documentation Control
Oversee document control systems to manage engineering drawings, specifications, procedures, and records.
Streamline the document revision process to guarantee accuracy and compliance.
Maintain and audit document repositories (e.g., IFS, ERP systems).
Support creation, revision, and formatting of controlled documents in collaboration with relevant departments.
Verify all documents comply with regulatory standards and internal procedures.
Train staff on document control procedures and system use.
Note: Please disregard any unrelated postings or notices that appear with this description.
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Job Summary:
The Quality & Compliance Specialist ensures that all organizational processes, products, and systems comply with internal standards and external regulations.
Key Responsibilities
Quality Management
Control and improve the Quality Management System (QMS) in accordance with ISO 9001:2015.
Conduct internal audits and lead corrective/preventive action (CAPA) initiatives.
Coordinate root cause analysis and continuous improvement activities.
Develop and implement quality improvement initiatives to enhance operational performance and customer satisfaction.
Ensure quality control metrics are tracked, reported, and acted upon.
Compliance
Champion adherence to industry standards and regulatory requirements (e.g., ISO, UL, NTEP, CE, REACH, RoHS, etc.).
Maintain required certifications and lead the organization’s preparation for external audits, inspections, and customer assessments.
Partner with internal teams and external stakeholders to support regulatory submissions, customer audits, and third-party certification processes.
Stay ahead of evolving laws, standards, and industry requirements, proactively integrating updates into company practices and policies.
Documentation Control
Oversee document control systems to manage engineering drawings, specifications, procedures, and records.
Streamline the document revision process to guarantee accuracy and compliance.
Maintain and audit document repositories (e.g., IFS, ERP systems).
Support creation, revision, and formatting of controlled documents in collaboration with relevant departments.
Verify all documents comply with regulatory standards and internal procedures.
Train staff on document control procedures and system use.
Note: Please disregard any unrelated postings or notices that appear with this description.
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