Manufacturing Engineer
Our client, a well-established med tech company in Geneva, is seeking an experienced Manufacturing Engineer for a six-month contract. The successful candidate will support product design transfer to manufacturing and manage equipment qualification and validation.
This is a hands-on role requiring on-site presence to guarantee smooth production processes and compliance in a high-regulation environment.
Key Responsibilities:
- Design Transfer: Manage and facilitate the smooth transition of product designs from the development phase into manufacturing.
- Equipment Management: Review, maintain, and update procedures related to the maintenance and calibration of manufacturing equipment.
- Compliance Management: Handle change requests in compliance with FDA regulations, ensuring all processes meet stringent regulatory standards.
- CAPA & Deviation Management: Identify, investigate, and manage Corrective and Preventive Actions (CAPA) and deviations to maintain high-quality standards and resolve any issues in manufacturing processes.
- Equipment qualification and validation: Ensure compliant Qualification and validation of manufacturing equipments.
Profile:
- Education: Bachelor's degree in Engineering or a related technical field.
- Experience: Proven experience in the medical technology sector, with a focus on FDA compliance, CAPA, and deviation management.
- Good knowledge of all the equipment Qualification processes
- French and English fluent, written and spoken
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