What are the responsibilities and job description for the Senior Validation Engineer position at EnIn Systems?
Job Description :
We are seeking a highly skilled Senior Validation Engineer to join our team in the MedTech / Medical Devices sector. The successful candidate will play a critical role in ensuring the quality and compliance of products, systems, and processes in accordance with regulatory requirements.
Key Responsibilities :
- Lead validation activities for medical devices, software, or systems, ensuring compliance with FDA, ISO, and other regulatory standards (e.g., 21 CFR Part 820, ISO 13485).
- Develop, review, and execute validation protocols (IQ, OQ, PQ), including writing validation plans, reports, and specifications.
- Coordinate and lead cross-functional teams to complete validation tasks and support product lifecycle management.
- Review and approve engineering changes and deviations, ensuring that validation is maintained throughout the product lifecycle.
- Perform risk analysis and implement corrective actions to resolve issues in the validation process.
- Conduct design reviews and ensure validation requirements are addressed early in the design phase.
- Maintain and update documentation to ensure that all validation processes are well-documented and easily auditable.
- Provide technical leadership and mentorship to junior validation engineers.
- Collaborate with R&D, Quality Assurance, and Manufacturing teams to ensure effective validation execution.
- Ensure that validation processes align with company quality systems, processes, and objectives.
Qualifications :
Preferred Qualifications :
