Key Responsibilities
1. QMS Implementation & Maintenance
• Develop, implement, and maintain the Quality Management System in line with ISO standards and regulatory requirements.
• Ensure proper documentation and control of quality manuals, procedures, SOPs, and work instructions.
• Maintain document control processes and ensure version control.
2. Compliance & Audits
• Plan and conduct internal quality audits.
• Support external audits, certification audits, and regulatory inspections.
• Ensure compliance with applicable quality standards and regulations.
3. Process Improvement
• Identify opportunities for continuous improvement within quality processes.
• Drive initiatives such as CAPA (Corrective and Preventive Actions).
• Monitor KPIs related to quality performance.
4. Training & Awareness
• Provide QMS training to employees.
• Promote a quality culture within the organization.
• Ensure staff understand quality procedures and compliance requirements.
5. Risk Management
• Support risk management activities (FMEA, risk assessments).
• Ensure quality risks are identified, documented, and mitigated.
6. Documentation & Reporting
• Maintain quality records and documentation.
• Prepare quality reports, audit reports, and management review inputs.
• Track quality metrics and improvement initiatives.
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Qualifications
• Bachelor’s degree in Engineering, Quality Management, Life Sciences, or related field.
• Certification in ISO 9001, ISO 13485, or Lead Auditor is preferred.
• Knowledge of quality tools (CAPA, Root Cause Analysis, FMEA, 8D).
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Experience
• 3–7 years of experience in Quality Management Systems or Quality Assurance.
• Experience with internal/external audits and regulatory compliance.
• Familiarity with document control systems and QMS software.
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Key Skills
• Strong knowledge of Quality Management Systems standards.
• Analytical and problem-solving skills.
• Excellent documentation and communication skills.
• Attention to detail and regulatory awareness.
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Preferred Skills
• Experience in regulated industries (medical devices, pharmaceuticals, manufacturing, aerospace).
• Knowledge of Six Sigma, Lean, or continuous improvement methodologies.