Validation Specialist
vor 2 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 our medical devices.
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 ISO requirements.
- Supporting and addressing comments and suggestions associated with validation and engineering documentation.
- Generating and approving protocol, deviation, and summary reports.
- Providing change control, non-conformance, and CAPA support.
To be successful in this role, you will need:
- A Bachelor's Degree in Engineering or Science.
- 2-5 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 and a thorough understanding of good documentation practice.
- Competence in tracking and updating schedules to provide upper management visibility of milestones and achievements.
- Proficiency in Microsoft Office tools.
- Knowledge of statistical techniques.
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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