Senior Manager, Quality System

Sonova Group; California (MO); Hybrid; USD 132,000 - 164,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

401k plan with company match

PTO and paid holidays

Hearing aid discount for employees and

family

Life/AD&D insurance

Disability Insurance

Parental bonding leave

Career growth opportunities

Employee assistance program

Job summary

Sonova seeks a Senior Manager, Quality Systems to lead core global quality system functions within Quality Assurance. This role ensures quality system processes operate effectively, compliantly, and in alignment with business needs across Advanced Bionics sites, overseeing audit management, CAPA, training, document control, records, and software validation.

The role emphasizes driving continuous improvement, regulatory compliance, and cross-functional leadership within a matrix environment.

Qualifications

• BA/BS degree required, or demonstrated equivalent experience; graduate degree in science or business preferred.
• 6+ years in GMP/QSR/ISO-regulated medical device environment.
• 3+ years of Class III medical device experience within Quality.
• Strong knowledge of quality system regulations and documentation.
• Proven leadership and cross-functional collaboration skills.

Responsibilities

• Lead core global quality system functions incl. audit management, CAPA, training management, document control, records, and software validation.
• Develop and improve global quality system processes to meet regulatory and business needs.
• Set quality system goals and metrics; report on performance and risks.
• Oversee internal and external audits and inspections by regulatory bodies.
• Coach and develop team members through performance management and planning.

Skills

GMP experience

QSR experience

ISO 13485

Leadership

Regulatory compliance

Education

BA/BS degree

Graduate degree preferred

Job description

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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.

Senior Manager, Quality System

164552

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

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
• Hearing aid discount for employees and family
• Internal social recognition platform

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.

Sonova is an equal opportunity employer

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