Engineer

This position is 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.

Requirements

:Knowledge of
FDA, GMPs and ISO requirements.

:Knowledge in
Organizational Excellence and Lean/Six Sigma.

:Knowledge in
Supplier Management program requirements.

:Fully bilingual (English and Spanish).

:Availability to work extended hours in a day and weekends as required.

:Availability to travel (US and/or Internationally) as required.

:Knowledge in
Microsoft Suite of Products including Word, Excel, Power Point, Outlook or similar, MS Project and Minitab.

:Must have a
BS in Engineering, preferably Mechanical, Industrial, Electrical, Chemical, or Biomedical
and
minimum
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.

:Must have experience in
resolving supplier quality problems.

:Experience in
validations
such as: manufacturing equipment, materials / suppliers, and packaging materials, among others.

:Experience in materials sciences, biomedical materials, packaging materials and biocompatibility testing
is a plus.