· Support
supplier transfer projects and serve as primary liaison for all actions
associated with new supplier requirements
· Transfer
of components and raw materials to new suppliers
· Continuously
monitor risk of the existing suppliers /components and define risk mitigation
plans
· Support
the transfer of product improvements into production utilizing Design for
Manufacturing (DFM) principles.
· Lead
analysis of defective components in Incoming Inspection and work with vendors
to resolve
· Manage
supplier process validation activities by applying a risk based approach
· Implement
continuous improvement within supply chain
· Lead/support
the supplier evaluation process when selecting & qualifying new suppliers; help
maintain the ASL, supplier scorecards, and supporting documentation required
per SOPs
· Resolve
incoming inspection yield issues by driving tighter vendor process capabilities
and ensuring appropriate internal drawing tolerances
· Ensure
compliance of manufacturing processes and areas to all applicable quality
system regulations
· Monitor
and analyze production information to support risk management and to provide
direction for corrective and preventive actions and/or process improvement
activities (CAPA)
· Validate
manufacturing and supplier processes, including activities associated with
equipment installation qualification (IQ), operational qualification (OQ), and
performance qualification (PQ)
· Work
with manufacturing engineering and supply chain to ensure necessary process
controls and validations are in place and best practices are followed (GMP)
· Identify
key process input variables and key process output variables.