Senior Manager, Quality Systems (Valencia (CA), United States)

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
• Don't meet all the criteria? If you’re willing to go all in and learn we'd love to hear from you!
• We are looking forward to receiving your application via our online job application platform. For this position only direct applications will be considered. Sonova does not recruit via app, telegram, carrier pigeon or any other format that does not include speaking with an actual human. If you are offered a job without speaking with someone please contact Sonova Human Resources
• 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
• 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.
• 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.
• 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
• 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