Beschreibung
We have a new opportunity for an experienced quality assurance/validation consultant to take charge for collaboration with suppliers and production risk management.Major Activities:
reviewing the technical file remediation to ensure externally manufactured products meet EU MDR requirements.
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: 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. coordinate activities 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 as applicable. Support Supplier Quality Functional Impact Assessments as applicable. Support Review and Approval of supplier Process Validation Protocols and Reports as applicable. Support the update of supplier related Inspection Criteria as applicable.
Experience requirement:
Prior experience as Supplier Quality engineer/validation in the medical devices 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
Knowledge of ISO 13485 and FDA QSR is required.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.