Responsible for the validation of new suppliers, raw materials and/or components as well as evaluation and qualification of changes informed by the suppliers. Responsibilities include serve as the plant expert in the raw materials / suppliers' qualification and provide technical support to other functional areas on this matter. Must be able to handle supplier quality situations and interactions in a tactful, professional and effective manner.
:Plan and qualify changes in components and/or raw materials requested by the suppliers following applicable procedures.
:Coordinate and approve First Article Inspection of new and/or existing components and/or raw materials.
:Provide timely awareness to management of changes in components and/or raw materials requested by the suppliers, associated conflicts, unexpected events, or other situations that may impact the business continuity.
:Formally and effectively communicate potential misses at the time of discovery along with the date that a specific quantitative action plan will be available to recover from the missed commitment.
:Develop and issue change control documentation to address changes in components and/or raw materials requested by the suppliers following applicable procedures.
:Conduct technical and statistical investigation on supplier quality problems found during qualification process.
:Performs cost analyses and inventory projections because of engineering projects. Prepares cost and time estimates for engineering and project schedules.
:Generation and execution of validation plans, validation protocols, and completion reports. Provide statistical analysis of the data to support the reports.
:Evaluate, investigate and document non:conformances incidents and/or protocol deviations.
:Evaluate and determine appropriate actions to resolve conflicts and/or unexpected events as to prevent and/or minimize impact on business and product supply commitments.
:Complete assigned Non:Conformance and CAPA investigations and prepare investigation reports.
Requirements
:Must have a strong background developing and executing change controls, validation protocols, engineering change orders, project management, among others.
:Must have experience in resolving supplier quality problems.
:Experience in validations related to changes notified by suppliers such as: discontinuation of parts/component/raw material, changes in raw material, changes in supplier manufacturing process, new parts designs, new facilities, specifications changes, new / refurbished molds, vendor name changes, among others, is strongly desired.
:Experience in validations such as: manufacturing equipment, materials / suppliers, and packaging materials, among others.
EDUCATION:
:BS in Engineering, preferably Mechanical, Industrial, Electrical, Chemical, or Biomedical.
:Minimum of 5 : 7 years of experience in the medical device and/or pharmaceutical manufacturing environment; with at least five (5) years in a manufacturing process, quality or validation engineering position and preferably with exposure to components and/or raw materials validations.
:PE License is a plus.
:Lean/Six Sigma Green or Black Belt Certification is a plus.
:Experience in materials sciences, biomedical materials, packaging materials and biocompatibility testing is a plus.
