Validation Specialist
vor 4 Wochen
We are seeking a skilled Validation Engineer to join our team at Randstad.
This is an exciting opportunity to work in a dynamic and collaborative environment, where you will be responsible for ensuring the quality and compliance of medical devices.
The ideal candidate will have a strong background in engineering or science, with experience in validation and quality assurance. Fluency in French is required, and proficiency in English is a plus.
Your key responsibilities will include:
- Developing and executing validation protocols, including the generation and approval of summary documentation.
- Collaborating with project teams to develop validation strategies and statistically sound tests.
- Completing test method validation, gauges R&R studies, and other qualifications or studies to support product testing.
- Scheduling coordination, material allocation, and alignment of personnel to successfully complete validation assignments.
- Developing statistically based sampling plans for in-process and final test sequencing.
- Ensuring compliance with cGMP, cGLP, QSR, and other applicable requirements.
- Supporting and addressing comments and suggestions associated with validation and engineering documentation.
- Protocol, deviation, and summary report generation and approval.
- Change control, non-conformance, and CAPA support.
Your profile should include:
- 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.
- 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.
- Knowledge of statistical techniques.
We offer a dynamic and supportive work environment, with opportunities for growth and development. If you are a motivated and detail-oriented individual with a passion for quality and compliance, we encourage you to apply for this exciting opportunity.
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