Supplier Validation Engineer

Company Description

QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

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Job Description
Responsible for thevalidation of new suppliers, raw materials and/or componentsas well asevaluation and qualification of changesinformed by the suppliers. Responsibilities include serve as the plant expert in theraw materials / suppliers’ qualificationand provide technical support to other functional areas on this matter. Must be able tohandle supplier quality situationsand interactions in a tactful, professional and effective manner.

Requirements

- Must have astrong background developing and executing change controls, validation protocols, engineering change orders, project management, among others.
- Must have experience inresolving supplier quality problems.
- Experience invalidations related to changesnotified by supplierssuch 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.

Qualifications

EDUCATION:
- BS in Engineering, preferablyMechanical, Industrial, Electrical, Chemical, or Biomedical.
- Minimum of5 - 7 years of experience in the medical device and/or pharmaceutical manufacturing environment; with at least five (5) years in amanufacturing process, quality or validation engineeringposition and preferably with exposure tocomponents 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.

Additional Information

- Bachelor in Engineering,preferably Mechanical, Industrial, Electrical, Chemical, or Biomedical
- Must be available no later than 1 week after selection