Validation Engineer

Title :Validation Engineer

Location :Arlington TN (Onsite)

Duration: Contract

Visa Any valid visa except OPT/CPT/J1

Mazak I200 experience mandatory

Job Description:

• Background from Quality Mazaak i200 and EMC Oven Machine 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 FMEAs risk mitigation plant validations; DOEs and other experiments and investigations as assigned.
• Working knowledge of Validations IQ OQ PQ SIMS and DOEs 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.
• Coordinate 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:

• Bachelors degree preferably Manufacturing Industrial Engineering

Skills:

• Bachelors degree in science engineering or manufacturing discipline
• Experience in ISO13485 certified and cGMP organizations preferred. Medical device manufacturing
• Background from Quality Mazaak i200 and EMC Oven Machine Validation