Senior Engineer, Operations Quality

Sonova AG•Santa Clarita, CA

3d•Onsite

About The Position

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, including compliance with 21CFR820, ISO13485, ISO 14971, MDSAP and MDR.

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

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.

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