Job Title: Quality Assurance Associate
Job Summary:
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:
* Adhere to quality procedures and specifications.
* Coordinate the collection and packing of customer samples.
* Ensure retain samples are kept and logged for all medical batches.
* Monitor production, highlight, and resolve non-adherence to quality procedures and specifications.
* Assist in resolving quality-related issues in production, ensuring issues are documented correctly.
* Participate in team investigations for customer complaints as requested.
* Carry out product audits.
* Complete First Piece, In-process, and Certificate of Analysis (COA) for medical, industrial, and automotive products as required.
* Issue batch documentation, including data record sheets, labels, etc., to production at the start-up of medical batches.
* Perform product inspections where required.
* Complete product measurements, including DOE, for validation purposes.
* 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.