Sr Quality Engineer

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.