Validation Engineer

Job Description & Skill Requirement

 ·         Acts as a resource to work for groups and project teams, within the plant and outside the plant relative to quality and validation-related activities.
·         Need to have familiarity with manufacturing processes and products to evaluate the cause and effect of defects and identify trends in machining process and product quality
·         Provides technical input for projects using the application of FMEAs, risk mitigation, plant validations; DOE’s’ and other experiments and investigations as assigned.
·         Working knowledge of Validations, IQ, OQ, PQ, MSA, and DOE is desirable.
·         Should possess good knowledge of the Machining process and its defect remediation activities.
·         Should have a good understanding and experience in GD&T and complex drawing interpretation.
·         Should have hands-on experience in creating PFMEA and Process control plans.
·         Should operate autonomously to review vendor documents, identify gaps, and work with others to close the gaps. Approve and assist in the Launch of products.
·         Co-ordinate with the Vendor to complete the PPAP documentation.
·         Should have sound experience in Non – conformance identification, RCA, CAPA, and implementation from a medical device manufacturing background.
·         Proven track record of supporting and driving continuous improvement activities in a production environment.

Qualification:

Bachelor’s degree preferably Manufacturing, Industrial Engineering

Experience in ISO-13485 & ISO-27001 certified and cGMP organizations preferred. Medical device manufacturing,
·         Experience in OnePLM and product life cycle management tool.