Senior Manager, Quality System

Sonova USA Inc.; California (MO); Hybrid; USD 131,156 - 164,450; Full time

Benefits offered by this job

Medical/dental/vision

401k match

Life/AD&D insurance

STD/LTD

PTO/holidays

Tuition reimbursement

Hearing aid discount

EAP

Career growth

Job summary

Sonova USA Inc. in Valencia, CA, seeks a Senior Manager of Quality Systems to lead global quality system functions, audits, CAPA and document control in a hybrid work environment.

You will shape quality processes to meet ISO13485/MDSAP/EU MDR requirements and report on performance and risks across sites. The role requires 6+ years in GMP/QSR/ISO medical devices, 3+ years in Class III quality, and strong leadership with cross-functional collaboration.

Qualifications

• BA/BS degree required, or demonstrated equivalent experience; graduate degree in science or business preferred
• 6+ years of experience in GMP, QSR, and ISO-regulated medical device environment
• 5+ years of progressive management experience in a cross-functional matrix
• 3+ years of Class III medical device experience within a Quality function
• Strong knowledge of quality system regulations: ISO 13485, MDSAP, EU MDR, 21 CFR 820, Part 11
• Proven experience developing, improving and maintaining quality system documentation and processes
• Strong leadership, communication, analytical, problem-solving and stakeholder management skills

Responsibilities

• Lead core global quality system functions: 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

Job description

Senior Manager, Quality Systems

Valencia, CA

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.

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

Qualifications

• 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.

If you don't meet all criteria but are willing to learn we would love to hear from you.

Benefits

• 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: $131,1560 - $164,450. This role is also commission eligible/bonus eligible.

Work Environment

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.

Equal Opportunity Employer

We team up. We grow talent. We collaborate with people of diverse backgrounds to win with the best team in the marketplace. 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.