Validation Engineer - Katalyst Healthcares & Life Sciences

Responsibilities:

• 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 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.

Requirements:

• Bachelor's degree preferably Manufacturing, Industrial Engineering
• 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