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.
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).
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.
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.
Preferred Skills
Experience in regulated industries (medical devices, pharmaceuticals, manufacturing, aerospace).
Knowledge of Six Sigma, Lean, or continuous improvement methodologies.
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