Validation Engineer - Lakeland, United States - Katalyst Healthcares & Life Sciences

Description

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