Job Title: Quality Assurance Specialist
This is a critical role in our organization, where you will be responsible for ensuring the quality and integrity of our products. As a Validation Engineer, you will support all validation activities associated with the successful qualification of new tools and product introductions.
About This Role:
* You will work closely with cross-functional teams to develop and implement solutions to sustain and improve the Quality Management System (QMS).
* You will maintain and support compliance to ISO 13485 and ISO 14001 systems standards.
* You will participate in site change control, ensuring that all changes to validated processes are effectively identified and implemented.
Key Responsibilities:
1. Write and execute process validation protocols and reports for new product introductions and revalidations due to process/material improvements utilizing scientific/technical knowledge.
2. Developing and implementing solutions to sustain and improve the QMS.
3. Maintain and support compliance to ISO 13485 and ISO 14001 systems standards.
4. Participate in the site change control, ensuring that all changes to validated processes are effectively identified and implemented.
Required Skills and Qualifications:
* Third-level qualification in Engineering, Polymer Science, or equivalent.
* Experience in statistical analysis (Minitab)/SPC/validations.
* Excellent interpersonal, communication, influencing, and facilitation skills.
Benefits:
We offer a competitive salary and benefits package, including opportunities for professional growth and development.
Candidates must have: A minimum of 5 years experience working with Medical Devices, Strong expertise and knowledge of Injection Moulding, Proven track record in validation within regulated environments.