QA System & Document Control Engineer

Main Tasks & Responsibilities

*** Maintain Integrated Management Systems

1. Design, implement, and continuously improve ISO-compliant management systems, ensuring cross-standard synergy and operational efficiency.

2. Plan and conduct internal audits (system, process, product) annually, deliver audit reports, and drive CAPA (Corrective and Preventive Actions) closure.

3. Manage external audits (certification bodies, customer audits), lead non-conformance resolution, and maintain valid certifications.

4. Monitor updates to ISO, RBA, and regional regulations, and adapt policies/procedures proactively.

*** Document Control & Lifecycle Management

5. Establish and enforce document control procedures, covering creation, review, approval, distribution, revision, obsolescence, and archiving.

6. Ensure traceability, version control, and compliance of technical documents (e.g., medical device technical files) and quality records.

7. Administer electronic document management systems (e.g., SharePoint, Documentum), optimizing access controls and audit trails.

*** RBA Compliance RBA

8. Implement RBA Code of Conduct across operations and supply chain.

9. Lead RBA audit preparation, execution and corrective action follow-up.

10. Deliver RBA training programs to enhance organizational awareness.

*** ESG & CSRD Integration ESG

11. Support ESG strategy development and KPIs for sustainability.

12. Track CSRD requirements and draft ESG disclosures.

13. Collaborate on sustainability initiatives (e.g., circular economy).

14. Other tasks assigned by line manager.

*** NOTE: Candidate must download and fill in the application form at the link below (maximum 4 pages), then attach it together with your CV.

https://docs.google.com/document/d/1m_QgM9HFDyyLrxACbU_EwS1D0ovRXFSP/edit

Education:

Bachelor's degree or above in Quality Management, Mechanical Engineering, Industrial Engineering or related field

Technical Profile:

- 3-5 years of QMS or document control experience in manufacturing industry

- Proficient in quality standards (ISO 9001/ISO 13485) with certification preferred

Preference:

Certified internal auditor

Critical Competences:

- Strong communication and coordination skills, with the ability to collaborate effectively across different levels and departments.

- Advanced skills in MS Office and document management systems

- Strong cross-functional communication and project coordination skills

- Knowledge of digital document management system implementation

Communication Profile:

Ability to communicate in oral and written English