Engineer

Job Description 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, GMP's 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.