Validation Engineer
Validation Engineer
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Salary Not Disclosed
1 Vacancy
Job Description
- Software quality assurance or software validation.
- Preferably within the medical device industry.
- Strong knowledge of FDA 21 CFR Part 820 ISO 13485 IEC 62304.
- Experience in non-product software validation.
- Includes tools for development testing maintenance.
- Deep understanding of quality standards and regulatory requirements:
- FDA 21 CFR Part 820.
- ISO 13485.
- IEC 62304.
- Software quality assurance.
- Software validation.
- Non-product software tools (for testing dev maintenance.)
- Strong multitasking and prioritization.
- Interpret and respond to regulatory & customer requirements quickly.
- Work in teams and solve problems independently.
- Validation Responsibilities:
- Plan schedule organize validation for new and existing applications from:
- Manufacturing.
- Quality Control.
- Clinical.
- R&D departments.
- Draft review & approve.
- User Requirements (URS) Functional Specifications Design Specs.
- Configuration Specs.
- Deviation and non-conformance reports.
- SOPs related to QMS.
- Prepare & review audit trails risk assessments GxP applicability.
- Author Validation Plans & Summary Reports.
- Perform traceability matrix creation.
- Cross-Department Interaction.
- Interact with stakeholders for cooperation and validation approvals.
- Work closely with Quality and Compliance teams.
- Participate in audits internal vendor and regulatory.
- Regulatory Alignment.
- Ensure compliance with internal SOPs forms and Periodic Review procedures.
- Conduct QMS and regulatory training.
Employment Type
Full-time
