QMS Executive
3 weeks ago
The QMS Executive is responsible for ensuring that the organization's Quality Management System (QMS) complies with internal standards, industry regulations, and customer requirements.
The QMS Executive plays a crucial role in driving the organization's commitment to delivering high-quality products or services while meeting regulatory and certification standards.
Requirements
Key Responsibilities:
QMS Maintenance and Improvement:
- Develop, implement, and maintain the organization's Quality Management System (QMS) based on relevant standards (e.g., ISO 9001, ISO 13485, etc.).
- Regularly review, update, and improve QMS documentation, procedures, and work instructions.
- Conduct internal audits to assess the effectiveness of the QMS and identify opportunities for improvement.
- Ensure corrective and preventive actions (CAPA) are effectively implemented and tracked.
- Develop, implement, and maintain the organization's Quality Management System (QMS) based on relevant standards (e.g., ISO 9001, ISO 13485, etc.).
Compliance and Standards Management:
- Ensure QMS activities align with applicable industry standards and regulatory requirements.
- Support external audits and regulatory inspections (e.g., ISO audits, regulatory body inspections) and ensure successful outcomes.
- Prepare and manage documentation for regulatory certifications and recertifications.
- Ensure QMS activities align with applicable industry standards and regulatory requirements.
Quality Assurance Activities:
- Coordinate and support quality assurance functions, including quality control, product inspections, and testing.
- Conduct root cause analysis of non-conformities, manage documentation, and lead initiatives for process improvements.
- Monitor key quality metrics and generate reports for management review.
- Coordinate and support quality assurance functions, including quality control, product inspections, and testing.
Training and Awareness:
- Conduct QMS-related training sessions for employees, ensuring understanding and adherence to quality policies and procedures.
- Promote a quality-centric culture within the organization by fostering awareness of QMS standards.
- Conduct QMS-related training sessions for employees, ensuring understanding and adherence to quality policies and procedures.
Documentation Control:
- Manage and maintain the control of quality documentation, including procedures, records, and reports, ensuring that all documents are up to date and compliant with QMS requirements.
- Ensure traceability and record retention according to established standards.
- Manage and maintain the control of quality documentation, including procedures, records, and reports, ensuring that all documents are up to date and compliant with QMS requirements.
Collaboration and Communication:
- Work closely with cross-functional teams (e.g., operations, production, and supply chain) to ensure quality objectives are met.
- Communicate effectively with external parties, including vendors, suppliers, and regulatory bodies, regarding quality-related matters.
- Work closely with cross-functional teams (e.g., operations, production, and supply chain) to ensure quality objectives are met.
Requirements
QMS QMS Documentation Quality Assurance ISO Document Operations Management
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