A global medical devices company has a need for a validation consultant to join the project to implement compliance framework for new MDR regulation
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.
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 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.
EDUCATION & EXPERIENCE REQUIREMENTS:
bachelor’s degree or equivalent in engineering or associated technical field is required.
Quality engineering experience in the medical device and/or pharmaceutical industry is required. Familiarity with ISO 13485 and FDA QSR is required.
Excellent organizational skills and attention to detail is required.
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 process
Fluency in English and German languages is needed
Michael Bailey International is acting as an Employment Business in relation to this vacancy.