Senior Manager, Quality System

Sonova AG • Santa Clarita, CA

1d • $131,156 - $164,450 • Hybrid

About The Position

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.

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 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

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

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior