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Quality Assurance Systems Specialist
2 months ago
Quality Assurance Systems Specialist Summary: The Quality Assurance Systems Specialist will play a pivotal role in spearheading the creation and execution of ISO certifications from inception. This position is essential for establishing a comprehensive quality management framework (QMF) that adheres to ISO standards, ensuring regulatory compliance, and fostering ongoing enhancement. The specialist will design, develop, implement, sustain, and refine the organization's management systems while collaborating with departmental leadership to secure and uphold certifications.
Key Responsibilities:
- Formulate, execute, and uphold a thorough quality management framework (QMF) to attain ISO certifications (ISO 9001, ISO 22001, ISO 14001, ISO 19011, ISO 50001, ISO 45001, etc.)
- Oversee the ISO certification journey, encompassing gap assessments, documentation, training, and audit readiness.
- Perform internal audits to verify adherence to ISO standards and pinpoint opportunities for enhancement.
- Engage with cross-functional teams to embed ISO standards into all operational facets.
- Generate and revise quality documentation, policies, procedures, and operational instructions.
- Educate and assist staff on quality management protocols and ISO standards.
- Track and report on the efficacy of the QMF and promote continuous improvement initiatives.
- Remain informed about updates in ISO standards to ensure the QMF's compliance.
- Stay abreast of environmental regulations.
- Manage corrective actions effectively.
- Strategic Planning (SWOT analysis).
- Integrate new methodologies and quality tools.
- Ensure the maintenance of the organization's management system.
- Implement best practices within the QMF.
- Adhere to quality GMPs and safety protocols.
- Perform additional tasks as assigned by management.
Qualifications: (This list is not exhaustive of all responsibilities the employee may be expected to undertake.) To excel in this role, candidates must possess:
- A Bachelor's degree in engineering, quality management, or a related discipline.
- A minimum of 5 years of experience in quality systems engineering or a comparable position, with a focus on ISO certification.
- In-depth knowledge of ISO 9001, ISO 14001, and other pertinent ISO standards.
- Demonstrated experience in developing and implementing QMF from the ground up.
- Exceptional problem-solving and analytical capabilities.
- Strong written and verbal communication skills in both English and Spanish.
- A collaborative approach to working with diverse departments.
- Proficiency in quality management software and tools.
- ISO Lead Auditor certification or similar credentials preferred.
- Experience in the manufacturing or industrial sector is advantageous.
