Senior Manager, Quality System

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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.

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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.

• 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

• 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 200

Mb/sec download and 10

Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee functionality at Sonova

• Medical, dental and vision coverage*
• Health Savings, Health Reimbursement, Flexible Spending/Dependent Care Accounts
• Tele Health options
• 401k plan with company match*
• Company…