Key Responsibilities
- 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.
- Compliance & Audits
- Plan and conduct internal quality audits.
- Support external audits, certification audits, and regulatory inspections.
- Ensure compliance with applicable quality standards and regulations.
- 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.
- Training & Awareness
- Provide QMS training to employees.
- Promote a quality culture within the organization.
- Ensure staff understand quality procedures and compliance requirements.
- Risk Management
- Support risk management activities (FMEA, risk assessments).
- Ensure quality risks are identified, documented, and mitigated.
- 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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