Posted: 12 February
Offer description
Job Purpose:
To support the Quality Operations Manager in implementing the Quality Management System and assisting the overall quality team.
Key Responsibilities:
1. Monitor finished parts production and release to ensure adherence to quality policies and procedures daily, according to the Quality Management System.
2. Maintain production GMP standards.
3. Investigate root causes and implement effective corrective actions to prevent recurrence of customer and internal quality issues.
4. Initiate and complete CAPA actions as required.
5. Initiate and complete engineering change requests and actions as required.
6. Initiate and complete non-conformance reports (NCRs) as required, coordinating product/production-related NCRs to closure in a timely manner.
7. Establish and monitor inspection standards, plans, frequencies, and test methods.
8. Establish and maintain FMEAs.
9. Prepare and update quality system documentation.
10. Support customer and surveillance accreditation audits.
11. Participate actively in quality planning and new product introduction from a quality perspective.
12. Develop strong links with customer organizations and other project stakeholders.
13. Validation experience is advantageous (not essential).
14. Contribute to the further development and continuous improvement of the quality management system.
15. Support Operations area projects and initiatives.
16. Train new or existing personnel on quality procedures and documentation; ensure production personnel are trained for their tasks and that procedures are in place.
17. Understand customer documents, i.e., Drawings, Purchase Specifications, Quality Agreements, etc.
18. Ensure that on-hold material is dispositioned and actioned in a timely manner.
19. Ensure that all retained samples are stored correctly and that the sample storage area is maintained.
20. Ensure that all quality records are completed per procedure and comply with GDP.
21. Adhere to incoming control requirements and support the SCAR process when required.
22. Audit experience is advantageous (not essential).
Minimum Qualifications:
Interested applicants should hold a relevant 3rd level qualification and/or equivalent quality experience, ideally in high-volume manufacturing.
Skills:
1. Good communication and interpersonal skills.
2. Ability to work as a team player and independently.
3. Proactive and solutions-driven approach.
