Your role will involve collaboration with suppliers to obtain details for manufacturing process information, production risk, management processes.
performing and supporting tasks related to the technical file remediation products to meet EU MDR requirements. 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 such as (Direct part marking documentation, Manufacturing Process Information, Production risk management file, Validation protocols and other reports)
Partner with Supply Chain to support EU MDR supplier communications and rollout of EU MDR
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.
Know and follow all laws and policies that apply to one's job, and maintain the
highest levels of professionalism, ethics and compliance at all times.
PROFESSIONAL EXPERIENCE REQUIREMENTS:
Experience as a Project Engineer, Quality Engineer, Project Manager or equivalent role
within the medical devices industry.
experience in a supervisory capacity is required.
Experience with ISO-13485 and FDA QSR is required.
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
* 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
German language is an advantage.
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