About this opportunity
Sonova USA Inc. lists this Senior Engineer, Operations Quality opportunity in california, Missouri. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Who we are
At Sonova, we envision a world where everyone can enjoy the delight of hearing. This vision inspires us and fuels our commitment to developing innovative solutions that improve hearing health and human connection - from personal audio devices and wireless communication systems to hearing aids and cochlear implants. We're dedicated to providing outstanding customer experiences through our global audiological care services, ensuring that everyone has the opportunity to engage fully with the world around them.
Guided by a culture of continuous improvement that fosters resilience and self-motivation, our team is united by a shared commitment to excellence and a deep sense of pride in our work, each of us playing a vital role in creating meaningful change,
Here you'll find a diverse range of opportunities that span both consumer and medical solutions and the freedom to shape your career while making an impact on the lives of others. Join us in our mission to create a more connected world, where every voice is heard and every story matters.
Valencia, CA (On-Site)
Senior Engineer, Operations Quality
Advanced Bionics is seeking an on-site Senior Engineer, Operations Quality to support compliance, manufacturing quality, and operational excellence for implant and external products. This role is responsible for ensuring Manufacturing Controls are compliant with procedures, regulatory requirements, internal standards, and international standards, including 21 CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR. This role partners closely with Manufacturing, Operations, Quality Control, Supplier Quality, Receiving Inspection, Engineering, Clinical, Regulatory, and cross-functional teams to help ensure products meet quality, regulatory, and performance expectations.
Responsibilities
Manage Manufacturing Quality Assurance activities for multiple related projects to ensure alignment 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
Provide expertise on international standards including ISO 13485, ISO 14971, 21 CFR 820, MDSAP, and EU MDR
Support design transfer, IQ, OQ, PQ, verification, validation, tooling, and manufacturing process testing activities
Participate in investigations and dispositions related to nonconformances, CAPA, NCMR, MRB, product changes, and root cause analysis
More about you
Bachelor's degree in Engineering required, or Associate's degree in Engineering with 7 years of equivalent work experience
Minimum of 5 years of Quality Engineering experience in medical device manufacturing required
Class III active implantable medical device experience preferred
Strong knowledge of quality practices, regulatory requirements, and manufacturing controls in a medical device environment
Ability to coach, mentor, and lead engineers without formal authority
Strong communication, professionalism, collaboration, and cross-functional partnership skills
Experience with project management, root cause analysis, process improvement, Six Sigma techniques, or advanced statistical analysis preferred
Microsoft Office and engineering software experience required; Agile PLM, SAP, Minitab, and CAD or solid modeling experience preferred
Travel
Up to 10%
A minimum of 200Mb/sec download and 10Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee functionality at Sonova
What we offer
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
*Plan rules/offerings dependent upon group Company/location.
This role's pay range is between: $100,320 - $124,400 annually. This role is also commission eligible/bonus eligible.
How we work
At Sonova, we prioritize the well-being of our employees and foster an inclusive environment that promotes engagement and collaboration. Our team-customized hybrid work model empowers teams to balance individual needs with business goals, offering flexibility and individualized time management. We recognize the importance of life outside of work and strive to create a supportive and motivating workplace where innovation thrives.
Sonova is an equal opportunity employer
We team up. We grow talent. We collaborate with people of diverse backgrounds to win with the best team in the market place. We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of a candidate's ethnic or national origin, religion, sexual orientation or marital status, gender, genetic identity, age, disability or any other legally protected status.
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Worksite address
california, MO, 65018, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.