Senior Engineer, Operations Quality

Sonova
United States
Workplace: HybridFull timeUSD 100,320 - 124,400 annuallyFunction: Quality & Regulatory (Non-Software)Experience: 5+ yearsEducation: bachelorsSkills: ["Communication","Cross-functional collaboration","Coaching and mentoring","Professionalism","Root cause analysis"]

Ensure manufacturing quality and compliance for implant and external products by aligning manufacturing controls with procedures, regulatory requirements, and internal/international standards. Lead quality assurance activities across multiple projects, partner with key manufacturing and quality stakeholders to streamline production, support audits, and drive investigations and root-cause analyses for nonconformances and CAPA. Work with design transfer and verification/validation activities to support operational excellence.

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FursaFursa
Sonova
Sonova
5 days ago

Senior Engineer, Operations Quality

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI
Last checked: 9 hours agoStatus: Live
Reposted: similar role first listed 7 months ago

Job Summary

Ensure manufacturing quality and compliance for implant and external products by aligning manufacturing controls with procedures, regulatory requirements, and internal/international standards. Lead quality assurance activities across multiple projects, partner with key manufacturing and quality stakeholders to streamline production, support audits, and drive investigations and root-cause analyses for nonconformances and CAPA. Work with design transfer and verification/validation activities to support operational excellence.
Location: United States
Workplace: Hybrid
Employment Type: Full time
Job Function: Quality & Regulatory (Non-Software)
Seniority: Mid level

Key Responsibilities

  • •Manage Manufacturing Quality Assurance activities across multiple related projects to align with strategic objectives.
  • •Partner with Receiving Inspection, Quality Control, Supplier Quality, Manufacturing, and Operations to support a streamlined manufacturing process.
  • •Support third-party audits related to manufacturing processes, procedures, and policies.
  • •Provide status reporting on manufacturing process deliverables, dependencies, risks, and issues.
  • •Investigate and help dispose nonconformances through CAPA, NCMR, MRB, product changes, and root cause analysis.
Travel: Low travel

Pay and Benefits

Salary: USD 100,320 - 124,400 annually
Perks:Health InsuranceDentalVision401kParental LeaveLife InsuranceDisability CoveragePaid Leave

Key Requirements

  • •Bachelor’s degree in Engineering required (or Associate’s degree in Engineering with 7 years of equivalent work experience).
  • •Minimum 5 years of Quality Engineering experience in medical device manufacturing.
  • •Strong knowledge of quality practices, regulatory requirements, and manufacturing controls in a medical device environment.
  • •Experience with project management, root cause analysis, process improvement, Six Sigma, or advanced statistical analysis (preferred).
  • •Microsoft Office and engineering software experience required; Agile PLM, SAP, Minitab, and CAD or solid modeling experience preferred.
Experience:5+ yearsMedical devices
Education:Bachelor's
Skills:CommunicationCross-functional collaborationCoaching and mentoringProfessionalismRoot cause analysis
Tech Stack:Microsoft OfficeAgile PLMSAPMinitabCADSolid modeling

Company Brief

Sonova
Designs, manufactures, and distributes hearing care solutions including hearing aids, cochlear implant accessories, and wireless communication devices, serving audiologists and consumers worldwide through clinics, retail networks, and distribution partners.
Industry: Medical Devices
Company Size: Enterprise (1,001+ employees)
Revenue: USD 1B+
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: Stäfa, Switzerland
Founded: 1947
Website