Quality Engineer III
- CAPA
- Risk Management
- FMEA
- Regulatory Compliance
- Six Sigma
- Lean
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Key Responsibilities
1. QMS Implementation & Maintenance
Develop, implement, and maintain theQuality Management System in line with ISO standards and regulatory requirements.
Ensure proper documentation and control ofquality manuals, procedures, SOPs, and work instructions.
Maintain document control processes and ensure version control.
2. Compliance & Audits
Plan and conductinternal quality audits.
Supportexternal audits, certification audits, and regulatory inspections.
Ensure compliance with applicable quality standards and regulations.
3. Process Improvement
Identify opportunities forcontinuous improvement within quality processes.
Drive initiatives such asCAPA (Corrective and Preventive Actions).
Monitor KPIs related to quality performance.
4. Training & Awareness
ProvideQMS training to employees.
Promote aquality 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.
Preparequality reports, audit reports, and management review inputs.
Track quality metrics and improvement initiatives.
Qualifications
Bachelor’s degree inEngineering, Quality Management, Life Sciences, or related field.
Certification inISO 9001, ISO 13485, or Lead Auditor is preferred.
Knowledge ofquality tools (CAPA, Root Cause Analysis, FMEA, 8D).
Experience
3–7 years of experience in Quality Management Systems or Quality Assurance.
Experience withinternal/external audits and regulatory compliance.
Familiarity withdocument control systems and QMS software.
Key Skills
Strong knowledge ofQuality Management Systems standards.
Analytical and problem-solving skills.
Excellent documentation and communication skills.
Attention to detail and regulatory awareness.
Preferred Skills
Experience inregulated industries (medical devices, pharmaceuticals, manufacturing, aerospace).
Knowledge ofSix Sigma, Lean, or continuous improvement methodologies.
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Quality Engineer III · Jabil Inc.