Job Title: Quality Engineer
To assist the Quality Operations Manager in the implementation of the Quality Management System and support the overall quality team.
Key Responsibilities:
1. Monitor production and release of finished parts to ensure adherence to quality policies and procedures, in accordance with the Quality Management System.
2. Interface with customers to realize customer satisfaction.
3. Maintain production GMP standards.
4. Investigate root causes and implement corrective actions to prevent recurrence of quality issues.
5. Initiate and complete CAPA actions as required.
6. Initiate and complete engineering change requests and actions as required.
7. Initiate and complete non-conformance reports (NCRs) as required.
8. Establish and monitor inspection standards, plans, frequencies, and test methods.
9. Establish and maintain FMEAs.
10. Prepare and update quality system documentation.
11. Support customer and surveillance accreditation audits.
12. Participate in quality planning and new product introduction from a quality perspective.
13. Develop strong links with customer organizations and other project stakeholders.
14. Contribute to the further development and continuous improvement of the quality management system.
15. Support Operations area projects and initiatives.
16. Train personnel on quality procedures and documentation.
17. Understand customer documents.
18. Disposition on-hold material in a timely manner.
19. Ensure correct sample storage and maintenance.
20. Complete quality records per procedure and comply with GDP.
21. Adhere to incoming control requirements.
Requirements:
* A relevant 3rd level qualification or equivalent quality experience.
* High-volume manufacturing experience is ideal.
Skills:
* Good communication and interpersonal skills.
* Ability to work as a team player and independently.
* Proactive and solutions-driven approach.