Job Opportunity
This Validation Specialist position is based in Longford, Ireland. The successful candidate will report to the Validation Manager and contribute to achieving New Product Introduction objectives.
* Develop process validation protocols and reports for new product introductions and revalidations.
* Implement quality management systems (QMS) to sustain and improve compliance with ISO 13485 and ISO 14001 standards.
* Participate in site change control and generate risk assessments covering cleaning, validation, and process.
* Execute Factory Acceptance Testing and Site Acceptance Testing protocols.
* Support regulatory audits, prepare training modules, and perform data analysis.
* Implement continuous improvement through Lean Six Sigma methodologies.
The ideal candidate will have a third-level qualification in Engineering or equivalent manufacturing experience. Strong expertise in statistical analysis, SPC, and validations is also required, along with excellent interpersonal and communication skills.
A minimum of five years' experience working with Medical Devices is necessary, as well as strong knowledge of Injection Moulding and a proven track record in validation within regulated environments.
Key Responsibilities
This role involves supporting all validation activities for new tools and product introductions. The successful candidate will work closely with the Validation Engineer Manager to achieve New Product Introduction objectives.
Required Skills and Qualifications
The ideal candidate will possess a strong understanding of quality management systems (QMS), statistical analysis, and process validations. Excellent interpersonal and communication skills are essential for this role.
Benefits
This role offers a unique opportunity to work with a reputable organization and contribute to the development of new products.
Others
The company is committed to providing ongoing support and training for employees to ensure their continued growth and development.