- Support the dedicated team for New Product Introduction
- Aid in the development and execution of Engineering Studies, defining test strategies, and conducting data analysis
- Shape the Process Validation Strategy and oversee validation activities
- Lead the Test Method Validation (TMV) Strategy, oversight, and document release
- Approve Process Validation deliverables including Validation Assessment, IQ, OQ, PQ, and Validation Plan
- Contribute to projects focused on process enhancement and automation implementation
- Evaluate process modifications within the Change Management Process and determine their impact on Process Validation
- Create reports and presentations for both internal and external stakeholders
- Bachelor's Degree in a relevant technical field (Biomedical/Mechanical/Automation Engineering)
- Minimum 3 years of related experience in a manufacturing environment (Medical Device, pharmaceutical, automotive industries preferred) or an equivalent blend of education and experience
- Familiarity with highly regulated settings (knowledge of standards like ISO13485, CFR 21 part 820, and MDR)
- Proficiency in Six Sigma and/or Process Validation techniques within the MedTech sector is advantageous
- Strong communication skills in Italian and English, knowledge of German is a bonus
- Strong organizational capabilities - be meticulous and disciplined
- Self-motivation and the ability to work independently
- Effective oral and written communication skills to achieve departmental objectives
- Proactive, persistent, and resilient attitude
- Excellent communication abilities across various organizational levels
- Creative thinking skills to simplify complex scenarios into practical solutions
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Validation Quality Engineer - Mezzovico-Vira, Schweiz - Randstad
Beschreibung
Job Description
Randstad Inhouse Services (RIS) is aimed at supporting companies with a high need for flexible staffing to enhance labor flexibility, productivity, and efficiency.
Currently, for our partner Jabil Switzerland Manufacturing GmbH, we are seeking temporary staff for the role of Validation Quality Engineer. Join us and let's optimize new product introduction processes together!
Requirements
Your Skills
As a professional in this role, you should possess:
This position is located in Mezzovico with potential occasional work at the RARON site. The duration of this position is expected to be around 7 months.
If you are keen on joining a global organization that supports brands influencing global empowerment, please submit your application in English. We'd love to have you on board!