Sean Obar

Background

About Sean Obar

Twenty+ years as a Medical Device Quality Engineer and Manager. B.S. Manufacturing Engineering.Collaborate with teams and individuals to ensure compliant and cost-effective medical device quality systems. Career has included: create and integrate quality systems for two startup companies; write quality policies and procedures; internal and supplier auditing; host FDA inspections, notified body and customer audits; quality data trending and management review; support lean manufacturing; manage document control; document review and approval; CAPA; nonconforming material control and disposition; validation; apply standards and guidance documents; write manufacturing and inspection procedures; manage receiving inspection, product release, and calibration. Manufacturing process exposure: packaging, labeling, sterilization, coating, polishing, machining, welding, cleaning, electro-mechanical assembly in a Lean environment, inspection and test.