Job Opportunity
We are seeking a skilled Validation Engineer to join our team on a 12-month 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 teams, and suppliers to resolve quality issues.
* Execute Commissioning, Qualification, and Validation protocols efficiently in a multidisciplinary environment.
* Develop validation project protocols using a risk-based approach that meets regulatory requirements and industry practices.
* Manage internal and supplier non-conformances, CAPAs, RCA's, and investigations.
* Communicate and collaborate with suppliers regarding non-conformances and escalate corrective actions as needed.
* Improve internal manufacturing processes for company products.
* Critical assessment of internal and supplier change management activities.
* Perform PPAP tasks for supplier changes.
* Participate in creating new or modified procedures.
* Maintain KPIs for process and product quality.
* Analyze manufacturing-related complaints and product field actions.
Requirements:
* Bachelor's degree in a relevant field (Level 8).
* 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).