Senior Engineer, Operations Quality

Sonova Group

Valencia, CA, United States
$95,200pyr - $142,800pyr; bonus eligible; medical,...
On-site
21cfr820, iso13485, iso 14971, mdsap, mdr
Manufacturing quality assurance activities
Design transfer, iq/oq/pq, verification/validation
Sonova Group is seeking a Senior Engineer in Operations Quality for its Valencia, CA location. The role focuses on ensuring compliance with manufacturing quality standards and regulations for medical devices, particularly Class III Active Implantable Devices, while offering a supportive, flexible workplace culture

Job Summary

  • The Senior Engineer, Operations Quality is responsible for compliance to procedures and regulations for Manufacturing Controls of Implant and Externals Products and works within a multidisciplinary product development team to ensure the design intent of products is realized effectively and efficiently.
  • Plans, executes, and documents testing activities including design transfer, IQ/OQ/PQ, and verification/validation of manufacturing processes, equipment, and tooling.
  • Sonova prioritizes the well-being of our employees and fosters an inclusive environment that promotes engagement and collaboration.

Matching Summary

Match Score: 85

Sonova Group is seeking a Senior Engineer in Operations Quality for its Valencia, CA location. The role focuses on ensuring compliance with manufacturing quality standards and regulations for medical devices, particularly Class III Active Implantable Devices, while offering a supportive, flexible workplace culture.

Salary

$95,200/yr - $142,800/yr; Bonus eligible; Medical, dental, vision, 401k, PTO, etc.

Skills & Requirements

Must-have

  • 21CFR820, ISO13485, ISO 14971, MDSAP, MDR
  • Manufacturing Quality Assurance activities
  • Design transfer, IQ/OQ/PQ, verification/validation
  • Continuous improvement, CAPA, NCMR, MRB
  • Root-cause analysis for products, systems, processes

Nice-to-have

  • Interpersonal and leadership skills
  • Consensus building
  • Spanish bilingualism
  • Agile PLM, SAP, Minitab, CAD/solid modeling

Key Requirements

  • Bachelor’s degree in engineering or equivalent experience
  • 5+ years Quality Engineering experience
  • Medical Device Manufacturing experience
  • Class III Active Implantable Devices experience preferred
  • Fluent in English

Work Rights

Not specified

Tailored Resume

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