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Quality Engineer III

3-7 Years
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Job Description

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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Job ID: 146158685