The QMS Audit & Compliance Engineer will manage the Quality Management System, conduct audits, develop compliance procedures, handle CAPA, and promote quality awareness among employees.
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
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