Valencia, CA - Onsite
Sr. Engineer, Operations Quality 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: - Lead Manufacturing Quality Assurance activities across multiple projects, ensuring alignment with strategic objectives and supporting compliant, efficient manufacturing operations.
- Partner with Receiving Inspection, Quality Control, Supplier Quality, Manufacturing, and Operations teams to maintain streamlined production processes, support audits, and communicate project status, risks, dependencies, and deliverables to management and stakeholders.
- Provide subject matter expertise on the implementation, interpretation, and compliance of medical device regulations and standards, including ISO 13485, ISO 14971, 21 CFR 820, MDSAP, EU MDR, and other applicable international requirements.
- Collaborate with Engineering, Marketing, Clinical, and Regulatory teams to define requirements and ensure products consistently meet specifications, regulatory expectations, and quality standards.
- Plan, execute, and report on manufacturing validation and verification activities, including design transfer, IQ, OQ, PQ, process validation, tooling qualification, and related testing programs.
- Drive continuous improvement initiatives by recommending and implementing process enhancements, supporting investigations, nonconformances, CAPAs, NCMRs, MRBs, change controls, and root cause analyses for products, systems, and processes.
- Support regulatory submissions, deliver compliance and quality training, mentor and guide team members, and serve as the Quality Assurance representative on cross-functional teams, GEMBA walks, and Manufacturing Kaizen events.
Travelling Requirement: up to 10%
More about you: - Bachelor's degree in Engineering or Associate's degree in Engineering with seven years of equivalent experience; advanced degree in Engineering, Certified Quality Engineer (CQE) certification, or other advanced technical degree is preferred.
- Minimum five years of Quality Engineering experience in medical device manufacturing, with experience supporting Class III Active Implantable Medical Devices considered highly desirable.
- Proven ability to work effectively with all levels of management and lead, coach, or influence engineering teams without formal authority while fostering collaboration and consensus-building.
- Strong interpersonal and communication skills with the ability to work under pressure, meet project timelines, and collaborate successfully across departments and organizational levels.
- Demonstrated expertise in medical device quality practices, continuous improvement initiatives, professionalism, and effective stakeholder engagement within a regulated manufacturing environment.
- Strong competencies in project management, root cause investigation and analysis, process improvement methodologies, Six Sigma techniques, and advanced statistical analysis for problem-solving and decision-making.
- Proficiency in English, Microsoft Office, and engineering software, with bilingual Spanish skills and experience using Agile PLM, SAP, Minitab, CAD, and solid modeling applications considered a plus.
A minimum of 200Mb/sec download and 10Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee functionality at SonovaDon't meet all the criteria? If you're willing to go all in and learn we'd love to hear from you!
We are looking forward to receiving your application via our online job application platform. For this position only direct applications will be considered. Sonova does not recruit via app, telegram, carrier pigeon or any other format that does not include speaking with an actual human. If you are offered a job without speaking with someone please contact Sonova Human Resources
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/yr - $150,480/yr. 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.
