Supplier Quality Engineer, Eu Mdr

QLS are recruiting for a Supplier Quality Engineer, EU MDR, to join a project with a Global Medical Device Company based in Solothurn on a contract basis for 12 months.
**Project Goal**:
To ensure all externally manufactured Company’s products meet new EU MDR requirements. EU MDR SQE will work under the direction of the EU MDR SQ project supervisor.
**Deliverables**:
The EU MDR SQE will evaluate the supplier’s manufacturing process information, production risk management, process controls, validation and direct part marking documentation against MDR Requirements; collaborate with the supplier to revise existing or developnew manufacturing process information, production risk management, process controls, validation and/or direct part marking documentation as applicable.

**Responsibilities**:

- Become a working member of the technical file remediation efforts to ensure externally manufactured Company’s products meet EU MDR requirements. This includes supporting project deliverables; meeting project timelines; resolving identified supplier issuesand executing the overall project related to technical file remediation requirements.
- Assess supplier drawings and process information to support project deliverables:

- Manufacturing Process Information and Controls; Production risk management file; Validation protocols and reports; Direct part marking documentation: 2D barecode implementation, etching validation and TMV.
- 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 Review and Approval EU MDR Change Projects as applicable and Review and Approval of supplier Process Validation Protocols and Reports as applicable.
- Support Supplier Quality Functional Impact Assessments as applicable and support the update of supplier related Inspection Criteria as applicable.
- A minimum of a bachelor’s degree or equivalent in engineering or associated technical field
- A minimum of 3 years’ experience in a quality engineering
- A minimum of 2 years’ experience in the medical device and/or pharmaceutical industry
- Familiarity with ISO 13485 and FDA QSR is required. Excellent organizational skills and attention to detail is required.
- Must be able to work independently and prioritize with limited supervision.
- Strong written and oral communication and interpersonal skills. Excellent computer, communication, and written skills are required. Proficient in Microsoft Office suite is required

**Preferred Skills**:

- Three years’ experience as Supplier Quality engineer; Supplier Process Validation engineer; Project Engineer, Project Manager or equivalent role within regulated industry.
- Understanding supplier management and validation procedures and execution
- 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

**Apply**:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 54859 in all correspondence.