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Posted 1w ago

Principal Quality Engineer

@ Viant
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San Antonio or Tijuana or San Diego
RemoteFull Time
Responsibilities:Leading NPI, Improve processes, Validate tests
Requirements Summary:Bachelor's degree in engineering; 10+ years direct medical device manufacturing experience with Quality Engineering; Spanish required; willing to travel up to 75%; knowledge of FDA Part 820 and ISO 13485.
Technical Tools Mentioned:Minitab, Excel, Microsoft Office
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Job Description

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 6,000 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 Medical’s website or on LinkedIn.

About the role:

This Principal Quality Engineer position is a corporate role responsible for Viant’s supporting Viant’s 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 regulators.

Work Model: Remote anywhere in United States or Tijuana, Baja California, MX
Travel Requirement: 50%-75% travel across Viant locations in Costa Rica, Tijuana, BC Mexico, and Vega Baja, Puerto Rico.  

What you'll do: 

  • 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

Requirements:

Education: 

  • Bachelor’s degree; engineering is preferred but not required

Experience: 

  • 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.
  • Background in injection molding, automation, manual assembly, sub‑assemblies, 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 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.
Viant is a global medical device design and manufacturing services provider that partners and innovates with customers to provide the highest quality, life enhancing medical devices. We do this through our depth and breadth of capabilities, end-to-end integration, technical expertise, and relentless focus on our customers and on operational excellence. With nearly 6,000 associates across 24 locations worldwide, we offer a unique combination of small-company service and attention with big-company resources. For more information, visit viantmedical.com or follow us on LinkedIn.                                                                                                                                                                                    
 
Viant provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.