Supplier Quality Engineer
ProClinical is currently recruiting for a Supplier Quality Engineer to be contract based at their client's site in Bern, Switzerland. This Engineering role will 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.
- Become a working member of the technical file remediation efforts to ensure externally manufactured products meet EU MDR requirements. This includes supporting project deliverable; 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 deliverable: o Manufacturing Process Information
- Production risk management file
- Validation protocols and reports
- Direct part marking documentation
- Work with Suppliers to meet EU MDR requirements and resolve issues with obtaining Supplier Product information.
- Cross coordinate Work stream activities/inter-dependencies with other work stream and project teams.
- Partner with Supply Chain to support EU MDR supplier communications and rollout of EU MDR Supply Chain Work stream activities;
- Support definition and clarification of EU MDR supplier related process requirements.
- Support Review and Approval EU MDR Change Projects as applicable.
- Support Supplier Quality Functional Impact Assessments as applicable.
- Support Review and Approval of supplier Process Validation Protocols and Reports as applicable.
Skills and Requirements:
- A minimum of a bachelor's degree or equivalent in engineering
- Three years' experience as Supplier Quality engineer; Supplier Process Validation engineer; Project Engineer, Project Manager or equivalent role within regulated industry.
- Familiarity with ISO 13485 and FDA QSR is required.
- Strong background in Medical Device Regulatory Compliance/Regulatory Affairs.
- Experience working with suppliers across multiple sites and franchises.
- Ability to act as an SME in supplier business processes.
- Experience with medical device technical files.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Sasha Brasero on +44 203 078 9556 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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