Valencia, CA
Senior Manager, Quality Systems
Advanced Bionics is seeking a Senior Manager, Quality Systems to lead core global quality system functions within the Quality Assurance organization. This role is responsible for ensuring quality system processes operate effectively, compliantly, and in alignment with business needs across Advanced Bionics sites. This leader will oversee key quality system areas including audit management, CAPA, training management, document control, records, and computerized quality system software validation while driving continuous improvement and regulatory compliance.
Responsibilities:
• Lead core global quality system functions, including internal and external audit management, distributor audit management, CAPA, training management, document control, records, and computerized quality system software validation
• Develop, maintain, and continuously improve global quality system processes and procedures to meet regulatory and business requirements
• Establish quality system goals, metrics, and operating mechanisms to assess and improve effectiveness across Advanced Bionics sites
• Provide leadership reporting on quality system performance, compliance status, risks, trends, and improvement opportunities
• Manage the internal audit program and support external audits and inspections by regulatory agencies and notified bodies
• Oversee distributor audit processes in alignment with regulatory requirements, quality agreements, and risk-based principles
• Coach, develop, and manage team members through performance management, development planning, hiring, and resource planning
More about you:
• BA/BS degree required, or demonstrated equivalent experience; graduate degree in science or business preferred
• 6+ years of experience in a GMP, QSR, and ISO-regulated medical device environment
• 5+ years of progressive management experience and experience working in a cross-functional matrix environment
• 3+ years of Class III medical device experience within a Quality function
• Strong knowledge of quality system regulations, including ISO 13485, MDSAP, EU MDR, 21 CFR 820, and Part 11
• Proven experience developing, improving, and maintaining quality system documentation and processes
• Strong leadership, communication, analytical, problem-solving, and stakeholder management skills
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!
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
*Plan rules/offerings dependent upon group Company/location
This role's pay range is between: $131,1560 - $164,450 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.
Around 25% of the world’s population is living with hearing loss. At Sonova, we envision a world where everyone enjoys the delight of hearing and lives a life without limitations. From personal audio devices and wireless communication systems to audiological care services, hearing aids, and cochlear implants. Our product brands – Phonak, Unitron, Sennheiser (under license), and Advanced Bionics – create compelling new products to offer the optimal solution for an ever growing consumer base through our globally diversified sales and distribution channels, including our well established global audiological care business. With a presence in over 100 countries and more than 19,000 employees, we leverage our global infrastructure and local roots. We aim for an inclusive work environment and culture that fosters a good balance of family and work-life for everyone. Our workforce is made up of 110 nationalities across 4 generations.
In 2006, Sonova founded the non-profit Hear the World Foundation, which seeks to give children living with hearing loss access to audiological care in low- to middle-income countries.
