Sonova Group · 13 hours ago
Senior Engineer, Operations Quality
Santa Clarita, CA
Full-time
Hybrid
Mid, Senior Level
$95K/yr - $143K/yr
5+ years expSonova Group is a leader in the medical device industry, seeking a Senior Engineer, Operations Quality. The role involves ensuring compliance with manufacturing controls for implant and external products while collaborating with cross-functional teams to enhance quality assurance processes.
Medical Device
Responsibilities
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
Qualification
Required
Holds a bachelor's degree in engineering (or equivalent experience)
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
A minimum of 200Mb/sec download and 10Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee functionality at Sonova
Preferred
An advanced engineering degree or Certified Quality Engineer credential
Spanish bilingualism is a plus
Familiarity with Agile PLM, SAP, Minitab, and CAD/solid modeling
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
Company paid Short/Long-Term Disability coverage (STD/LTD)
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
Company
Sonova Group
Around 25% of the world’s population is living with hearing loss.
10001+ employees
H1B Sponsorship
Sonova Group has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (3)
2023 (1)
2022 (3)
2020 (1)
Funding
Current Stage
Late StageLeadership Team
Kimberly Cleary, Au.D.
Chief Operating Officer Sonova Audiological Care US
Rosalie Lewis
Sr. Manager, HR Business Partnership
Recent News
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