Principal Quality Engineer

Viant•San Diego, CA

8d•Remote

About The Position

This Principal Quality Engineer position is a corporate role responsible for supporting Viant’s Tijuana, Puerto Rico, and Costa Rica sites. The role involves supporting the Quality Management System, implementing compliance continuous improvement projects, and supporting both Quality and Operations with New Product Introduction (NPI) and ongoing manufacturing. The position will report to the Vice President of Quality of the MDS Division and will work closely with all Viant Operations and Quality associates, as well as customers and third-party regulators. The work model is remote, and the position requires 50%-75% travel across Viant locations in Costa Rica, Tijuana, BC Mexico, and Vega Baja, Puerto Rico.

Requirements

Bachelor’s degree; engineering is preferred but not required.
Direct medical device manufacturing experience (10+ years) with Quality Engineering proficiency.
Experience within regulated industries such as Pharmaceuticals, Medical Devices, Automotive, or Aerospace.
Strong understanding of statistical methodologies and regulatory 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 Regulations.
Experience with FDA Inspections and ISO Audits.
Strong background in process validations and sampling plans.
Experience with quality system metrics and manufacturing data analysis, trending, and process capabilities.
Proficient with Quality System software applications.
Ability to perform computer-related tasks using software including: Microsoft Office, Minitab, and/or others as needed.

Nice To Haves

Background in injection molding, automation, manual assembly, sub‑assemblies, PCV, and extrusion.
Working knowledge of statistical analysis in Minitab and Excel.

Responsibilities

Participate in and lead NPI projects for new and existing customers.
Develop 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 reports.
Write and perform test method validations.
Write and/or improve manufacturing Work Instructions and Test Methods.
Work directly with customers to facilitate and optimize new product transfers and current product improvements.
Support site level Quality Teams to implement improvement projects targeting compliance.
Assist manufacturing sites in the implementation of quality system software as appropriate.
Statistically analyze quality data to identify trends or other issues.
Assist manufacturing sites with continuous improvement programs to address negative metric trending and results.
Perform other tasks as assigned.