Supplier Validation Engineer
- Contract
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.
Log on now to our website http://www.qrcgroup.com/ to learn more about our services and solutions!
Job Description
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
- 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.
Qualifications
- 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.
Additional Information
All your information will be kept confidential according to EEO guidelines.