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Supplier Quality Manager (Process Validation SME)
View: 158
Update day: 04-03-2024
Category: Quality Assurance / Quality Control
Industry: Medical Equipment Manufacturing
Position: Mid-Senior level
Job type: Full-time
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Job content
In this role, your core task is to intensify and further develop communication and cooperation with our suppliers. You are mainly responsible for quality management activities at Medela’s suppliers, validating their production processes, introducing process optimizations and thus ensuring the highest quality of the supplied products. If you like to work independently and push your topics forward, then you might be the right person.Join the Medela Family! We turn science into care.Your Responsibilities- Review and approval of supplier process validations, creation of Process Validation Plans and Reports
- Manage SCARs (Supplier Corrective Action Request) and successful conclusion as well as timely addressing of other gaps at suppliers through the tracking of robust corrective action plans
- Support Technical Changes, development and operational projects, ensuring successful implementation of processes at Medela’s suppliers
- Conduct supplier Quality audits, negotiating Quality Management Agreements with suppliers
- Maintenance of a Validation Master Plan
- Maintain technical documentation related to supplier’s processes
- Higher degree in Life sciences, Engineering or similar (Bachelor, Master)
- Profound expertise in Manufacturing Process Validations, Good knowledge of production techniques and processes
- Minimum 5 years’ experience in the Medical Device Industry
- Profound knowledge of Quality-Systems related to IS013485:2016; ISO 9001 :2015 desired
- Business fluent in English, other languages are an asset
- Strong problem-solving skills, ability to juggle many different cases and issues
- Experience conducting Supplier Quality Audits an asset
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Deadline: 18-04-2024
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