A new and exciting opportunity has arisen for a Validation Engineer with one of Cork's leading Medical Device companies on a 12 month hourly rate contract.
In this role, you will support quality assurance, control, and preventative activities with a focus on continuous improvement of internal products and processes.
Responsibilities:
* Collaborate with QA, cross functional and suppliers' teams to address quality issues.
* Execute Commissioning, Qualification, and Validation protocols efficiently while working in a multidisciplinary team.
* Develop protocols for validation projects using a risk-based approach that meets regulatory requirements and industry practices.
* Manage internal and supplier non-conformances.
* Manage identified internal CAPAs, RCA's and investigations.
* Communicate and collaborate with suppliers regarding non-conformances, escalating supplier corrective actions as required.
* Develop and improve internal manufacturing processes for company products.
* Perform critical assessments of internal and supplier change management activities.
* Carry out PPAP tasks for supplier changes.
* Participate and lead in the creation of new or modified procedures.
* Maintain KPIs for process and product quality.
* Execute and analyze manufacturing-related complaints and product field actions.
Required Qualification & Experience
* Level 8 Degree in a relevant field.
* 4 years of experience in Quality and Validation.
* Experience with regulatory agencies (FDA, MoH, TUV, etc.).
* Familiarity with ISO 13485, GDP, GMP regulations.
* Understanding of EU, US and other Medical Device Regulations.
* Strong knowledge of Quality concepts (e.g. Risk Management, CAPA, Audits, Statistics).
This is an opportunity to work with a leading Medical Device company in Cork.
You will need to have 4 years experience in a Quality or Validation role with knowledge of GMP regulations.