Manufacturing Engineer_Plastic moulding
Kelly Scientific is looking for a pharmaceutical company localized in Switzerland a Manufacturing Engineer specialized in plastic moulding.
Your mission :
Support Manufacturing and change control activities at subcontractors of products post regulatory approval. Maintain and review technical files.
Your responsibilities :
Provide technical support on manufacturing processes for Medical Devices at Subcontractors.
Your Profile :
- Support the validation activities (including revalidation) for manufacturing processes at subcontractors
- Lead improvement projects to sustain or improve the quality of the products, reduce the lead time and increase the yield
- Lead equipment maintenance and replacement projects
- Responsible for Design Verification test for Medical Devices
- Provide Technical & Manufacturing assistance during change control, complaints management or CAPA activities
- Maintain technical drawings for small changes. Participate in larger design change projects as technical support.
- Maintain the technical file documentation including the risk management file
- Maintain Device Master Record
- Participate in cross functional teams to create and implement manuals, guidelines, tools to facilitate and structure working processes
Your Kelly contact :
- Bachelor/Master degree science in Mechanical, micro technical, manufacturing Engineering or equivalent.
- 2 to 5-year experience in medical device manufacturing industry with demonstrated manufacturing support experience.
- Mandatory experience with injection moulding of plastic parts, precision metal components and sterilization processes
- Availability to travel 30%
- Experience in Cleanroom Engineering, Manufacturing, Computer Validation and Systems Qualification for industrial setting
- Experience with manual assembly procedures.
- Fluent in English and French is a plus
Sophie Darthenay, Consultant Professional Staffing Life Science |Engineer in Biology| Kelly Services (Suisse) SA, Rue du Rhône 114, 1204 Genève, Switzerland