Principal Quality Engineer

About the company:Viant is a global medical device partner providing design development manufacturing and assembly services through capabilities in materials plastics metals extrusion and automation. With nearly 6000 employees across 24 locations worldwide it delivers high quality life enhancing products with scale and expertise to bring devices to market efficiently. Learn more at Viant Medicals website or on the role:This Principal Quality Engineer position is a corporate role responsible for Viants supporting Viants Tijuana Puerto Rico and Costa Rica sites through working supporting the Quality Management System implementing compliance continuous improvement projects and support both Quality and Operations with NPI and on-going manufacturing. The position will report to the Vice President of Quality of the MDS Division and work closely with all Viant Operations and Quality associates as well as customers and third party Model: Remote anywhere in United States or Tijuana Baja California MXTravel Requirement: 50%-75% travel across Viant locations inCosta Rica Tijuana BC Mexico and Vega Baja Puerto youll do:Participate in and lead NPI projects for new and existing and/or improve manufacturing processes in support of NPI projects and continuous improvement efforts (i.e. NCR/Complaint reductions).Write and perform process validation protocols and and perform test method and/or improve manufacturing Work Instructions and Test directly with customers to facilitate and optimize new product transfers and current product site level Quality Teams to implement improvement projects targeting manufacturing sites in the implementation of quality system software as analyze quality data to identify trends or other manufacturing sites with continuous improvement programs to address negative metric trending and other tasks as assignedRequirements:Education:Bachelors degree; engineering is preferred but not requiredExperience:Direct medical device manufacturing experience (10 years) with Quality Engineering proficiencyExperience within regulated industries such as Pharmaceuticals Medical Devices Automotive or understanding of statistical methodologies and regulatory in injection molding automation manual assembly subassemblies PCV and extrusion (Preferred)Working knowledge of statistical analysis in Minitab and Excel. (Preferred)Requirements:Spanish proficiency (Required): Fluent professional Spanish & English (spoken and written)Ability to travel up to 75% to Viant sites (Costa Rica Tijuana BC Mexico and Vega Baja Puerto Rico)Strong working knowledge and familiarity with FDA Part 820 and ISO 13485 RegulationsExperience with FDA Inspections and ISO AuditsStrong background in process validations and sampling plansExperience with quality system metrics and manufacturing data analysis trending and process capabilitiesProficient with Quality System software applicationsAbility to perform computer-related tasks using software including: Microsoft Office Minitab and/or others as needed.