Senior Engineer, Operations Quality
Sonova Group
full-time
Posted on:
Location Type: Office
Location: Valencia • California • United States
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Salary
💰 $95,200 - $142,800 per year
Job Level
About the role
- Oversees all Manufacturing Quality Assurance activities across multiple projects to ensure alignment with strategic objectives and compliance with product specifications, regulatory requirements, and international standards.
- Collaborates with Receiving Inspection, Quality Control, Supplier Quality, and Manufacturing/Operations to maintain efficient processes, while supporting third-party audits and providing cross-functional status reporting on risks, issues, and deliverables.
- Interprets and applies global medical manufacturing standards (ISO 13485, ISO 14971, 21 CFR 820, MDSAP, EUMDR) and leads requirements gathering with Engineering, Marketing, Clinical, and Regulatory teams.
- Plans, executes, and documents testing activities including design transfer, IQ/OQ/PQ, and verification/validation of manufacturing processes, equipment, and tooling.
- Drives continuous improvement by recommending and implementing process enhancements, supporting investigations (CAPA, NCMR, MRB), and conducting root-cause analyses for products, systems, and processes.
- Contributes to regulatory submissions, delivers compliance training, mentors junior team members, and serves as the QA representative in cross-functional teams, GEMBA walks, Kaizen events, and general quality support activities.
Requirements
- Holds a bachelor’s degree in engineering (or equivalent experience); an advanced engineering degree or Certified Quality Engineer credential is preferred.
- Brings at least 5 years of Quality Engineering experience in Medical Device Manufacturing, ideally with Class III Active Implantable Devices.
- Demonstrates strong interpersonal and leadership skills, able to coach teams and collaborate across departments under pressure and tight timelines.
- Skilled in driving continuous improvement through consensus building, root cause analysis, Six Sigma, and advanced statistical problem-solving.
- Proficient in quality practices specific to medical devices, including regulatory standards such as ISO 13485, 21 CFR 820, and MDSAP.
- Fluent in English; Spanish bilingualism is a plus.
- Experienced with Microsoft Office and engineering software; familiarity with Agile PLM, SAP, Minitab, and CAD/solid modeling is preferred.
- A minimum of 200Mb/sec download and 10Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee functionality at Sonova
Benefits
- Medical, dental and vision coverage*
- Health Savings, Health Reimbursement, Flexible Spending/Dependent Care Accounts
- TeleHealth options
- 401k plan with company match*
- Company paid life/ad&d insurance
- Additional supplemental life/ad&d coverage available
- Company paid Short/Long-Term Disability coverage (STD/LTD)
- STD LTD Buy-ups available
- Accident/Hospital Indemnity coverage
- Legal/ID Theft Assistance
- PTO (or sick and vacation time), floating Diversity Day, & paid holidays*
- Paid parental bonding leave
- Employee Assistance Program (24/7 mental health support hotline, 5 company paid counseling sessions and more)
- Robust Internal Career Growth opportunities
- Tuition reimbursement
- Hearing aid discount for employees and family
- Internal social recognition platform
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Quality Engineeringroot cause analysisSix Sigmastatistical problem-solvingdesign transferIQ/OQ/PQverification/validationprocess enhancementsCAPANCMR
Soft skills
interpersonal skillsleadership skillscoachingcollaborationconsensus buildingcommunication under pressurementoringcross-functional teamworkproblem-solvingtime management
Certifications
Certified Quality Engineer