ISO Coordinator

Role Overview

We are hiring a meticulous ISO / GMP / CE Documentation Specialist to build, maintain, and control all compliance documentation required across our product portfolio. This role ensures that every document—SOPs, technical files, risk assessments, process records, regulatory submissions, and audit-ready materials—is accurate, current, and aligned with international quality standards.

This is a documentation-heavy role requiring exceptional attention to detail, strong process understanding, and the ability to collaborate closely with engineering, production, R&D, and regulatory teams.

Key Responsibilities

1. ISO Documentation Management

• Create, organize, and maintain documentation for:
• ISO 9001 QMS
• ISO 13485 (medical device processes), where applicable
• Own and manage:
• SOPs
• Work Instructions
• Quality Manuals
• Process flowcharts
• NCR/CAPA records
• Internal audit documentation
• Ensure document traceability, version control, and adherence to QMS requirements.

2. GMP Documentation

• Maintain GMP-required records including:
• Batch manufacturing records
• Device history records (DHR)
• Device master records (DMR)
• Calibration + maintenance logs
• Training records and competency matrices
• Ensure all logs and templates follow traceability, compliance, and regulatory formatting norms.

3. CE Documentation (Technical Files)

• Prepare and maintain CE Technical Documentation for each product:
• Essential Requirements/General Safety & Performance Checklist
• Risk Management File (ISO 14971-based)
• EMC/EMI/ESD test reports
• Labeling artwork, IFUs, packaging validation
• BOM traceability and component declarations (RoHS, REACH, etc.)
• DoC (Declaration of Conformity)
• Organize test evidence, third-party lab reports, and certifications for audit readiness.

4. Document Control & Compliance Tracking

• Own the complete document control system—creation, review, approval, release, archival.
• Manage controlled distribution of documents to production, engineering, R&D, and QC teams.
• Ensure expired/obsolete documents are removed or updated.
• Monitor compliance timelines, renewal dates, and corrective actions needing documentation updates.

5. Audit Support

• Prepare audit binders, evidence logs, and process documentation for:
• Internal audits
• ISO surveillance audits
• CE technical documentation reviews
• GMP inspections
• Ensure all required documents are audit-ready at all times.

6. Cross-Functional Coordination

• Work closely with engineering to capture design documentation.
• Work with manufacturing to document processes, QC steps, calibration procedures, and production records.
• Collaborate with regulatory teams for submissions, declarations, and compliance updates.
• Train internal teams on documentation discipline and QMS procedures.

Required Qualifications

• Bachelor’s degree (Engineering, Life Sciences, Quality Management, or related field).
• 1–4 years of experience specifically in ISO / GMP / CE documentation.
• Strong understanding of QMS frameworks and regulatory requirements.
• Excellent writing, document formatting, and technical editing skills.
• Familiarity with risk management, QC processes, and audit preparation.

Preferred Skills

• Experience working in electronics, medical devices, diagnostics, or instrumentation industries.
• Understanding of standards such as ISO 14971, IEC 60601, IEC 61010, RoHS, REACH, etc.
• Ability to interpret engineering drawings, test reports, and BOMs.
• Proficiency with document control software or QMS tools.
• Strong organizational and archival discipline.

What We Offer

• A role that directly strengthens our compliance backbone across multiple advanced instrumentation products.
• Exposure to real-world international certification workflows (ISO, CE, GMP).
• Clear growth path into Regulatory Affairs, Quality Systems, or Compliance Engineering roles.
• Competitive salary and performance-based growth opportunities.

Job Type: Full-time

Pay: ₹13,763.05 - ₹31,244.75 per month

Benefits:

• Provident Fund

Work Location: In person