Validation Specialist
Vor 3 Tagen
We are seeking a skilled Validation Specialist to join our team at Randstad. As a Validation Specialist, you will be responsible for ensuring the quality and safety of medical devices by developing and executing validation protocols. Your primary goal will be to guarantee that our clients' products meet the highest standards of regulatory compliance.
Key Responsibilities:
- Develop and execute validation protocols for medical devices
- Collaborate with project teams to develop validation strategies and statistically sound tests
- Complete test method validation, gauge R&R studies, and other qualifications or studies to support product testing
- Schedule coordination, material allocation, and alignment of personnel to successfully complete validation assignments
- Develop statistically based sampling plans for in-process and final test sequencing
- Ensure compliance with cGMP, cGLP, QSR, ISO, or other applicable requirements
- Support and address comments and suggestions associated with validation and engineering documentation
- Protocol, deviation, and summary report generation and approval
- Change control, non-conformance, and CAPA support
Requirements:
- Bachelor's Degree in Engineering (Biomedical, mechanical, chemical, or electrical) or Science (Biology, Chemistry)
- 2 to 5 years of experience in a Validation or Quality Assurance role for a medical device or pharmaceutical environment
- Fluency in French and good command of English
- Demonstrates excellent organizational and communication skills
- Experience with qualifying medical devices, manufacturing equipment, or external components
- Excellent technical writing skills with a thorough understanding of good documentation practice
- Competent in tracking and updating schedules to provide upper management visibility of milestones and achievements
- Use of Microsoft Office tools
- Knowledge of statistical techniques
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