Job Description
1.0 Overview The ISO Quality Manager is responsible for supporting the Quality Assurance Department with all ISO 9001-related quality assurance functions. This role provides oversight of the requirements for the ISO 9001 Quality Management System (QMS). The ISO Quality Manager ensures the ISO 9001 QMS consistently provides products and services that meet customer, statutory, and regulatory requirements. Additionally, the ISO Quality Manager enhances customer satisfaction through the effective application of the system, including process improvements and conformity assurance.
The ISO Quality Manager will interact with all departments within the company and may engage with regulatory agencies, customers, consultants, and vendors related to the ISO 9001 QMS needs.
2.0 Responsibilities
2.1 Primary Responsibilities to Support ISO 9001 QMS
Establish procedures and quality standards, monitoring these against agreed targets.
Lead the company's quality efforts to adapt to changes.
Provide support for quality issues encountered in DMSO and maintain the corporate ISO program.
Ensure compliance with ISO 9001 standards through thorough documentation and record retention.
Specific responsibilities include:
Quality Policy; Scope of QMS; Management review.
Process control through procedures, work instructions, and specifications.
Document control and revisions.
Training and competence management.
Risk and opportunity assessment; resource allocation.
Change management; Non-Conformance management; Product release oversight.
Calibration, maintenance, and traceability; Monitoring and measurement of processes.
Corrective actions; Process improvements.
Customer satisfaction and support; Post-delivery activities.
Communication of product requirements to customers.
Internal and external audits; Customer audits; Supplier quality management.
Product identification, traceability, retention, and preservation.
2.2 Additional Responsibilities
Maintain open communication with the QA Manager regarding revisions, updates, changes, non-conformances, or any other process-related activities affecting regulatory requirements.
Complete customer document requests associated with the ISO 9001 QMS.
Facilitate ISO 9001 quality-related investigations.
Lead investigations of customer complaints regarding quality concerns.
Schedule and lead audits for ISO 9001 QMS (internal, external, and customer audits).
Perform other duties as assigned.
3.0 Requirements
3.1 Experience
Minimum of 5 years of experience in an ISO 9001-regulated Quality position.
Working knowledge of manufacturing environments within an ISO 9001 framework.
3.2 Skills and Abilities
Strong understanding of analytical methods and manufacturing practices.
Excellent communication skills with proven ability to manage customer audits.
Demonstrates strong attention to detail.
Effective problem-solving skills with the ability to analyze information skillfully.
4.0 Physical and Safety Requirements
Daily exposure to production environments.
Observes safety and security procedures at all times.
5.0 Other Qualifications
Self-starter with the ability to work independently.
Innovative and creative in problem-solving.
Flexible and adaptable to evolving business needs.
This job description outlines the primary duties and qualifications for the ISO Quality Manager role and is subject to modification based on the company’s operational needs.
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