Quality Validation Specialist
Our organization is seeking a skilled Quality Validation Specialist to support the qualification of new tools and product introductions. This hands-on role will involve working within a dynamic manufacturing environment to ensure all validation activities are completed successfully.
About the Role:
The Quality Validation Specialist will be responsible for supporting the development and implementation of solutions to sustain and improve our Quality Management System (QMS). Key responsibilities include:
* Writing and executing process validation protocols and reports for new product introductions and revalidations due to process or material improvements;
* Maintaining and supporting compliance to ISO 13485 and ISO 14001 systems standards;
* Participating in site change control, ensuring that all changes to validated processes are effectively identified and implemented;
* Generating risk assessments covering cleaning, validation, and process review;
* Executing Factory Acceptance Testing and Site Acceptance Testing protocols.
Required Skills and Qualifications:
To be successful in this role, you will require:
* A third-level qualification in Engineering, Polymer Science, or an equivalent field;
* Manufacturing experience with a focus on statistical analysis (Minitab), SPC, and validations;
* Excellent interpersonal, communication, influencing, and facilitation skills;
* A minimum of two years' experience as a Validation Engineer within an injection molding or medical manufacturing environment.
Benefits:
We offer a range of benefits to support your growth and development, including:
* Opportunities for professional development and training;
* A collaborative and supportive work environment;
* Competitive compensation and benefits packages.
This is a fantastic opportunity to join a dynamic team and contribute to the success of our organization. If you have the required skills and qualifications, please apply now.
Key Responsibilities: Process validation protocols, ISO 13485, ISO 14001, Factory Acceptance Testing, Site Acceptance Testing