Randstad Professionals is currently looking for a Supplier Quality Engineer / validation Consultant (German speaker) who will be assigned an interesting challenge for a major client based close to Solothurn.
This contract is an unique opportunity to join a major client, global group focusing on the Healthcare / Medical device sector.
The initial assignment will start immediately and will last until December 2019
Contract details :
Start Date : 01 / 04 / 2019
Requisition End Date : 31 / 12 / 2019
To ensure all externally manufactured products meet new EU MDR requirements.
Collaborate with suppliers to obtain details for manufacturing process information, production risk management and direct part marking.
This information will be used to update the product’s technical file to be in compliance with Medical Device Regulations.
The EU MDR SQE will evaluate the supplier’s manufacturing process information, production risk management, direct part marking documentation against MDR Requirements;
collaborate with the supplier to revise existing or develop new manufacturing process information, production risk management and / or direct part marking documentation as applicable.
You will become a member of the technical file remediation efforts to ensure externally manufactured products meet EU MDR requirements.
This includes supporting project deliverables; meeting project timelines; resolving identified supplier issues and executing the overall project related to technical file remediation requirements.
Assess supplier drawings and process information to support project deliverables :
Direct part marking documentation
Manufacturing Process Information
Production risk management file
Validation protocols and reports
Work with Suppliers to meet EU MDR requirements and resolve issues with obtaining Supplier Product information.
Cross coordinate Workstream activities / interdependencies with other workstream and project teams.
Partner with Supply Chain to support EU MDR supplier communications and rollout of EU MDR
Supply Chain Workstream activities;
Support definition and clarification of EU MDR supplier related process requirements.
Support Review and Approval EU MDR Change Projects
Support Supplier Quality Functional Impact Assessments
Support Review and Approval of supplier Process Validation Protocols and Reports as applicable.
Support the update of supplier related Inspection Criteria
PROFESSIONAL EXPERIENCE REQUIREMENTS :
3 years as Project Engineer, Quality Engineer, Project Manager or equivalent role
within regulated industry.
A minimum of 3 years’ experience in a supervisory capacity is required.
A minimum of 2+ years of experience in a medical device and / or pharmaceutical industry is required.
ISO-13485 and FDA QSR is required.
Excellent organizational skills and attention to detail is required
Demonstrated ability to effectively define, plan and manage projects
Proven exceptional written and oral presentation skills
Experience with systems implementation / rollout projects preferred
EDUCATIONAL REQUIREMENTS :
A minimum of a bachelor’s degree or equivalent in engineering or associated technical field is required. A minimum of 3 years’ experience in a quality engineering is required.
OTHER REQUIREMENTS :
Understanding supplier validation procedures and execution.
Strong Project Management skills, must understand the critical path, identify program resources,
setup project plan and track execution, establish project structure and governance around critical projects.
Experience with GD&T, Inspection Methods, and Drawing Review / Approval.
Experience working with suppliers across multiple sites and business centers.
Process Excellence Black Belt or Master Black Belt
Must be highly organized, creative, articulate and analytical
If you are interested to learn more about this great opportunity, don’t hesitate to get in touch with me. Feel free to send me your CV at following email
I am looking forward to receiving your applications