Global Quality Systems Leader, Senior Manager

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

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.