Senior Engineer, Operations Quality (Valencia (CA), United States)

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.
Valencia, CA
Senior Engineer, Quality Assurance Operations (Onsite)
The Sr Operations Quality Assurance Engineer 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 and supplier quality to ensure a streamlined manufacturing process is maintained
• Support 3rd party audits regarding manufacturing processes and policies
• Experienced in class III sterile implantable medical devices
• 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 and 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 in the investigations and dispositions of product, non-conformances and changes, CAPA, NCMR, MRB
• As needed, prepares documentation for and support regulatory submissions (USA, EU, International)
• May create and/or delivery training on compliance of medical devices per international standards
• May mentor, train or otherwise provide guidance to newer or less experienced team members, leveraging product skills and experience
• General quality support as required and other duties as assigned.
• QA representative on cross functional teams, GEMBA walks, Manufacturing Kaizen Events
• Other duties as assigned.

Travelling Requirement: Up to 10%
More about you:
Education

• Bachelor's Degree (and/or # of years of equivalent work experience)

Work Experience

• 5 years of previous Quality Engineering in Medical Device Manufacturing

Nice to Have

• 5 years of previous Quality Engineering in Medical Device Manufacturing for Class III Active Implantable Devices

Language(s)/ Level

• English/ Proficient

Nice to Have

• Spanish/ Fluent

IT Skills

• Microsoft Office/Engineering Software

Nice to Have

• Agile PLM; SAP; Minitab; CAD / solid modeling knowledge, abilities and experience

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 all in and learn we'd love to hear from you!
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
• D&I focused: D&I council and employee resource groups

*Plan rules/offerings dependent upon group Company/location.
This role's pay range is between: $93,600/yr - $140,400/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.