Job Purpose:
The QMS Engineer is responsible for ensuring that the company’s Quality Management System (QMS) is maintained and improved in accordance with ISO 9001 standards and internal policies. The QMS Engineer works collaboratively across departments to enhance quality performance, lead audits, manage document control, and drive continuous improvement efforts to ensure product compliance with regulatory and company standards.
Duties and Responsibilities:
Document Control:
- Lead the management and control of all quality-related documents, ensuring proper drafting, approval, review, publication, and retrieval processes are followed.
- Regularly inspect document usage and storage, ensuring compliance with company policies.
- Manage the registration, control, issuance, and retrieval of external documents.
- Oversee record management, ensuring proper categorization, storage, and disposal in compliance with retention periods.
Internal Audits and Management Audits:
- Plan and execute internal audits as per the annual audit schedule, including documentation and reporting of non-conformities.
- Lead management audits, developing reports, and action plans for continuous improvement.
- Train and develop internal audit teams and ensure proper follow-up on corrective actions.
External Audits:
- Coordinate and facilitate external audits by preparing required documentation and ensuring all audit processes are executed smoothly.
- Follow up on corrective actions from external audits to ensure timely closure of non-conformances.
Quality Objective Management:
- Work with departments to set, track, and achieve quality objectives, ensuring alignment with the company’s strategic goals.
- Monitor monthly performance against objectives and implement corrective/preventive actions as necessary.
Training and Development:
- Organize and provide training on QMS-related topics, such as system management, document control, and internal auditing.
- Ensure the company’s quality-related training programs meet the needs of the organization and regulatory standards.
Quality Culture Promotion:
- Promote a culture of quality by organizing quality initiatives and programs aimed at increasing employee awareness and engagement.
- Track participation in quality culture activities and report on the impact.
Continuous Improvement:
- Lead or support quality improvement initiatives that enhance product quality, streamline processes, and reduce costs.
- Collaborate with cross-functional teams to identify opportunities for improvement and implement corrective actions.
Education and Experience:- Bachelor’s degree in Quality Management, Engineering, or a related field.
- 2+ years of experience working in a QMS role.
- Experience in a manufacturing environment preferred.
- Certified ISO 9001 Lead Auditor or similar certification is a plus.
Physical Requirements:- Must be able to sit, stand, and walk for extended periods, especially during audits or inspections.
- Ability to occasionally lift up to 25 pounds.
- Ability to travel occasionally for audit purposes.
Work Environment:- Standard office environment with occasional visits to production areas where PPE (personal protective equipment) is required.
- Regular working hours with occasional overtime during audits or key projects.