Senior Engineer, Operations Quality

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.

163819

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 21

CFR
820, ISO
13485, ISO 14971, MDSAP and MDR.

• 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%

• 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…