ISO Controller

Role & responsibilities

A. ISO System Development & Implementation

• Define and establish the ISO Management System, including policies, procedures, SOPs, work instructions, formats, and records.
• Translate ISO requirements into practical and effective business/shop-floor processes.
• Coordinate with process owners to implement and maintain required controls. • Identify gaps between documented procedures and actual practices and drive corrective actions. • Ensure periodic review and continual improvement of the Management System.

B. Document & Record Control

• Establish and maintain effective control of policies, manuals, procedures, SOPs, work instructions, formats, and records.
• Maintain the Master List of Controlled Documents.
• Ensure only current and approved documents are available at points of use.
• Control document revisions, approvals, distribution, withdrawal, and record retention.

C. Internal Audit Management

• Prepare and execute the Annual Internal Audit Plan covering all applicable processes/departments.
• Conduct or coordinate process and system audits based on risk, process importance, previous findings, complaints, and changes.
• Maintain trained internal auditors and ensure auditor independence.
• Issue audit reports and record NCs, observations, and opportunities for improvement.
• Track corrective actions and verify effectiveness before closure; analyze trends and recurring/systemic issues.

D. External / Certification Audit Management

• Act as the primary coordinator for Certification, Surveillance, Recertification, Customer, External Audits and Ensure audit readiness through pre-audit assessments and gap reviews.
• Coordinate with auditors and process owners during audits.
• Ensure timely submission and closure of external audit findings.
• Maintain complete audit history and corrective-action records.

E. CAPA & Non-Conformity Management

• Establish and control the system for internal, external, customer, and process non-conformities.
• Ensure effective Root Cause Analysis (RCA) and corrective action.
• Review action plans for adequacy and challenge ineffective actions.
• Monitor CAPA aging and escalate overdue actions.
• Verify implementation & effectiveness before closure; identify repeat failures, drive systemic actions.

F. Risk & Compliance Management

• Coordinate identification and periodic review of process risks and opportunities.
• Maintain the Risk & Opportunity Register.
• Coordinate monitoring of applicable statutory, regulatory, customer, and ISO requirements.
• Ensure changes in processes, products, equipment, or organization are evaluated for management-system impact.

G. Training & Awareness

• Prepare and execute the ISO awareness and internal auditor training plan.
• Conduct training on ISO requirements, procedures, audit methodology, RCA/CAPA, risk management, and quality awareness.
• Ensure employees understand requirements applicable to their processes and maintain training/competency records.

H. Management Review & Continual Improvement

• Coordinate Management Review Meetings and consolidate required inputs.
• Present audit status, NC/CAPA, customer feedback, process performance, objectives, risks, and improvement opportunities & Track actions arising from Management Reviews.
• Use audit findings, complaints, process performance, and risks to drive continual improvement.

Preferred candidate profile

• Bachelor's degree in Engineering / Science / Quality / Operations or equivalent.
• Certified ISO Internal Auditor / Lead Auditor for the applicable standard.
• 58 years of relevant experience in ISO, Quality, Management Systems experience preferred.
• Experience in certification, surveillance, customer and internal audits, with working knowledge of RCA, CAPA, Risk Management, Process Mapping, and Continuous Improvement.