Position Summary
The QMS Specialist is responsible for assisting the QA Manager in maintaining, implementing, and continuously improving the company’s integrated Quality, Environmental, Safety, and Health management systems. This role ensures full compliance with ISO 9001, IATF 16949, ISO 14001, ISO 45001, and ISO 13485, supports internal and external audits, and ensures effective document control, regulatory compliance, and timely closure of audit findings to sustain certification and customer requirements.
Responsibilities
- Assist the QA Manager in overseeing and maintaining the company’s integrated management systems in compliance with ISO 9001, IATF 16949, ISO 14001, ISO 45001, and ISO 13485.
- Maintain and control the Quality Manual and ensure controlled circulation under proper document security.
- Plan, coordinate, and ensure management reviews and internal audits are conducted according to the established schedule and as required.
- Coordinate customer, external, and internal audits, ensuring smooth execution, effective communication of findings, and timely follow-up actions.
- Ensure all findings from internal audits, external audits, customer audits, and system gap assessments are closed effectively and on time.
- Initiate and coordinate Management Review Meetings, typically following internal quality audits.
- Ensure the document control center and QMS records are properly maintained, controlled, and available at point of use.
- Continuously monitor, evaluate, and improve the QA system by identifying deficiencies and recommending corrective and preventive actions.
- Prepare and present quality performance summaries and QA departmental reports for management review.
- Ensure the Environmental Management System (EMS) and Occupational Safety & Health Management System (OSHMS) are implemented and maintained in accordance with applicable standards and company requirements.
- Ensure raw material substance declarations are updated and maintained in customer‑appointed systems or portals.
- Ensure the QESH management system complies with all applicable regulatory, legal, and other compliance requirements.
- Coordinate with certification bodies and external service providers regarding QESHMS certification and compliance requirements, and provide recommendations to top management.
Qualifications
- Minimum 5 years’ experience in a QMS role within a manufacturing environment.
- Bachelor’s Degree in Engineering, Quality, or related discipline.
- Hands‑on experience with ISO 9001, ISO 14001, ISO 45001.
- Experience with IATF 16949 and/or ISO 13485 is highly preferred.
- 1 to 2 years of progressive experience in occupational safety, industrial safety, or related field is preferred.
- Strong knowledge of ISO standards and audit practices.
- Good documentation, analytical, and problem‑solving skills.
- Able to work independently and manage multiple systems.
- Good communication and coordination skills.