Terms and Conditions
This is an internal fixed-term contract (maternity leave). This development role offers a valuable opportunity for the successful candidate to enhance their skills and gain hands-on experience within the QA Function in Plant 1.
Upon completion, you will resume your previous role under your existing terms and conditions of employment.
The Role
The Quality Team represents the Customer at Mergon International. The role of a Quality Assurance Associate is crucial in ensuring that products, services, and processes meet established quality standards and regulatory requirements. You will act as a guardian of quality, working to prevent defects, identify issues, and ensure compliance, ultimately contributing to customer satisfaction and regulatory adherence.
Key Responsibilities
1. Adhere to quality procedures and specifications.
2. Coordinate the collection and packing of customer samples.
3. Ensure retain samples are kept and logged for all medical batches.
4. Monitor production, highlight, and resolve non-adherence to quality procedures and specifications.
5. Assist in resolving quality-related issues in production, ensuring issues are documented correctly.
6. Participate in team investigations for customer complaints as requested.
7. Carry out product audits.
8. Complete First Piece, In-process, and Certificate of Analysis (COA) for medical, industrial, and automotive products as required.
9. Issue batch documentation, including data record sheets, labels, etc., to production at the start-up of medical batches.
10. Perform product inspections where required.
11. Complete product measurements, including DOE, for validation purposes.
12. Train production operators to ensure understanding of relevant specifications and procedures.
Key Relationships
- Quality Assurance Personnel: Collaborate within the Quality Team.
- Operations Leads / Production Manager: Liaise on Quality issues.
- Production Personnel: Receive training on product quality requirements and procedures.
- Engineering Department: Coordinate on Quality issues.
Decision Making
Quality Associates have the authority to place products on hold. A decision to stop production can be made in conjunction with the Operations lead.
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