Quality Engineer III

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.