Sonova

14 hours ago

Senior Manager, Quality System

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 14 hours agoStatus: Live

Job Summary

Lead global quality system functions within the Quality Assurance organization, ensuring processes run effectively, compliantly, and aligned to business needs across Advanced Bionics sites. Oversee audit management (internal, external, distributor), CAPA, training, document control, records, and computerized quality system validation. Set quality system goals and metrics, report performance and compliance risks, and manage the internal audit program while coaching and developing team members.

Location: United States

Workplace: Hybrid

Employment Type: Full time

Job Function: Quality & Regulatory (Non-Software)

Seniority: Sr. Manager level

Key Responsibilities

•Lead core global quality system functions including internal/external audit management, distributor audits, 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, including distributor audit processes in line with requirements and risk-based principles.

Pay and Benefits

Salary: USD 1,311,560 - 164,450 annually

Perks:Health InsuranceDentalVision401kPaid Parental

Key Requirements

•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 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.

Experience:GMPQSRISO-regulatedMedical deviceClass IIIQuality assurance

Education:Bachelor's

Skills:LeadershipCommunicationAnalyticalProblem-solvingStakeholder management

Company Brief

Sonova

Designs, manufactures, and distributes hearing care solutions including hearing aids, cochlear implant accessories, and wireless communication devices, serving audiologists and consumers worldwide through clinics, retail networks, and distribution partners.

Industry: Medical Devices

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: Stäfa, Switzerland

Founded: 1947

Website

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Sonova

14 hours ago

Senior Manager, Quality System

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 14 hours agoStatus: Live

Job Summary

Location: United States

Workplace: Hybrid

Employment Type: Full time

Job Function: Quality & Regulatory (Non-Software)

Seniority: Sr. Manager level

Key Responsibilities

•Lead core global quality system functions including internal/external audit management, distributor audits, 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, including distributor audit processes in line with requirements and risk-based principles.

Pay and Benefits

Salary: USD 1,311,560 - 164,450 annually

Perks:Health InsuranceDentalVision401kPaid Parental

Key Requirements

•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 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.

Experience:GMPQSRISO-regulatedMedical deviceClass IIIQuality assurance

Education:Bachelor's

Skills:LeadershipCommunicationAnalyticalProblem-solvingStakeholder management

Company Brief

Sonova

Industry: Medical Devices

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: Stäfa, Switzerland

Founded: 1947

Website