Job Title: Validation Engineer

Location: Arlington, TN (Onsite)

Job Description:

· Background from Quality Mazaak i200 and EMC Oven Machaine Validation

· Acts as a resource to work 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 titanium machining process and product quality

· Provides technical input for projects using the application of FMEA’s, risk mitigation, plant validations; DOE’s’ and other experiments and investigations as assigned.

· Working knowledge of Validations, IQ, OQ, PQ, SIMS and DOE's is desirable.

· Should possess good knowledge in Machining process and its defect remediation activities.

· Should have 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 to close the gaps. Approve and assist in Launch of products.

· Co-ordinate with Vendor to complete the PPAP documentation.

· Should have sound experience in Non – conformance identification, RCA, CAPA and implementation from 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

Skills:

· Bachelor’s degree in science, engineering, or manufacturing discipline

· Experience in ISO-13485 certified and cGMP organizations preferred. Medical device manufacturing,

· Background from Quality Mazaak i200 and EMC Oven Machine Validation