Device Qualification Engineer
vor 1 Tag
Randstad (Switzerland) Ltd. is a leading provider of recruitment services, offering a wide range of job opportunities in various industries.
Job DescriptionWe are seeking a skilled Validation engineer to join our team in the Canton of Neuchatel.
- Key Responsibilities:
- Develop and execute qualification/validation protocols, including summary documentation.
- Collaborate with project teams to create statistically sound tests and support results.
- Complete test method validation, R&R studies, and other qualifications or studies.
- Schedule coordination, material allocation, and personnel alignment for successful validation assignments.
- Ensure compliance with cGMP, cGLP, QSR, ISO, and other applicable requirements.
- Support and address comments and suggestions associated with validation and engineering documentation.
- Generate protocol, deviation, and summary reports.
- Provide change control, non-conformance, and CAPA support.
We are looking for a highly motivated individual with a Bachelor's Degree in Engineering (Biomedical, mechanical, chemical, or electrical) or Science (Biology, Chemistry).
- Required Skills and Qualifications:
- 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 knowledge of good documentation practice.
- Competent in tracking and updating schedules to provide upper management visibility of milestones and achievements.
- Familiarity with Microsoft office tools and statistical techniques.
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