QMS Audit & Compliance Engineer

Responsibilities

1. QMS Management & Compliance

• Maintain and improve the Quality Management System in accordance with ISO 9001 and relevant industry requirements (if any)
• Ensure compliance with regulatory, customer, and internal requirements.
• Develop, implement, and monitor QMS procedures, policies, and documentation.
• Lead document control processes, including revisions, approvals, and distribution.

2. Audit Management

• Plan, schedule, and conduct internal audits across departments and processes.
• Coordinate and support external audits (certification bodies, customers, regulatory agencies).
• Prepare audit checklists, conduct audit interviews, and document findings.
• Track audit findings, non-conformities, and corrective actions to closure.

3. CAPA & Non-Conformance Management

• Lead root cause analysis for non-conformities related to QMS and customer audits
• Ensure timely implementation and effectiveness of corrective and preventive actions (CAPA).
• Monitor trends and identify systemic quality issues.

4. Risk Management & Continuous Improvement

• Identify quality risks and implement risk mitigation strategies.
• Support QEs in risk assessment and mitigation on customer complaints related to QMS
• Support process improvement projects to enhance efficiency and compliance.

5. Training & Awareness

• Conduct QMS and compliance training sessions for employees.
• Promote quality culture and awareness across the organization.
• Support onboarding of new employees with QMS training.

6. Reporting & Documentation

• Prepare audit reports, compliance dashboards, and management review inputs.
• Maintain accurate records of audits, CAPA, and compliance activities.
• Provide regular reporting on QMS performance metrics.

Requirements

• Bachelor’s degree in Engineering, Quality Management, or related field.
• At least 3 years working experience related to Quality System Management and Auditing
• Certified Lead Auditor for ISO 9001:2015
• Ability to follow procedures and processes.
• Proficient with computer-based productivity tools (i.e. Microsoft Office)
• Proactive, energetic and can work in a fast-paced environment.
• Good verbal and written communication skills.
• Attention to details and able to work individually or as a team
• Versatile and have a keen interest in learning and solving problems