What are the responsibilities and job description for the Senior Engineer, Operations Quality position at Sonova?
Who we are
You enjoy creating and innovating. You never stop striving for better. You take responsibility and you get results. You love being part of a team. Above all, you want your work to matter : Welcome to our world! At Sonova we create sense by bringing sound to life. Our innovative hearing care solutions help millions of people enjoy life's unforgettable moments.
We offer exceptional career opportunities through market-leading brands from consumer to medical, products and services that keep pushing hearing care forward, and a culture where you can quickly belong and perform at your best.
If you want the freedom to explore, opportunities to grow, and make positive change on people lives through your work, this is the place for you.
Join Sonova. Create sense.
Valencia (CA), United States
Senior Engineer, Operations Quality
156648
Who we are
In a life without sound, our work provides meaning. As a leading provider of innovative hearing care solutions, we are not just a company that makes products : we are a team on a mission to help people enjoy the delight of hearing. To enable a life without limitations, through our core business brands - Advanced Bionics, Audiological Care, Phonak, Sennheiser (under license) and Unitron - we develop, manufacture and distribute solutions that push the limits of technology and redefine the future of our industry.
Senior Engineer, Operations Quality (Onsite)
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.
Responsibilities :
- Manages all Manufacturing Quality Assurance aspects of multiple related projects to ensure the overall program is aligned to and directly supports the achievement of strategic objectives
- Partnering with Receiving inspection, Quality control, supplier quality, and Manufacturing / Operations to ensure a streamlined manufacturing process is maintained
- Support 3rd party audits regarding manufacturing processes and policies
- Provides status reporting regarding manufacturing processes deliverable, dependencies, risks and issues, communicating across teams and to direct management
- Provides expertise to the manufacturing and design team on the implementation of international standards (ISO 14971, ISO 13485, particular standards, etc.) as they relate to manufactured product.
- Identification and interpretation of recognized standards for medical manufacturing (e.g. ISO 13485, 21 CFR 820, MDSAP, EUMDR etc.)
- Requirements discovery as solicited from Engineering, Marketing, Clinical, and Regulatory stakeholders
- Ensure product meets or exceeds product specifications, regulatory requirements, and international standards
- Responsible for various testing planning, execution and reporting, including design transfer, IQ, OQ, PQ. Verification and Validation of manufacturing processes and tooling etc.
- Recommends process improvements to management and executes to ensure consistent implementation of internal requirements and external regulations and standards.
- Participates / Supports investigations and dispositions of product, non- conformances and changes, CAPA, NCMR, MRB
- Supports / Reviews root cause analysis / assessments of products, systems, and processes.
- As needed, prepares documentation for and support regulatory submissions (USA, EU, International)
- Creates and / or delivers training on compliance of medical devices per international standards
- Mentor, train or otherwise provide guidance to newer or less experienced team members, leveraging product skills and experience
- QA representative on cross functional teams, GEMBA walks, and / or Manufacturing Kaizen Events
- Provides general quality support.
- Other duties as assigned.
Travelling Requirement : up to 10%
More about you : Education
Nice to Have
Further Education
Nice to Have
Work Experience
Nice to Have
Personal Competencies
Social Competencies
Leadership Competencies
Professional Competencies
Nice to Have
Language(s) / Level
Nice to Have
IT Skills
Nice to Have
A minimum of 200Mb / sec download and 10Mb / sec upload speed internet connectivity is required to support any remote / hybrid employee functionality at Sonova
Don't meet all the criteria? If you're willing to go allin and learn we'd love to hear from you!
What we offer :
Additional supplemental life / ad&d coverage available
STD LTD Buy-ups available
This role's pay range is between $94,400 / yr - $141,600 / yr (based on location). This role is also 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.
Salary : $94,400 - $141,600
