Senior Quality Engineer

Sonendo, Inc. • Laguna Hills, CA

44d • $103,000 - $126,400

About The Position

Sonendo, Inc. is a medical technology company with a unique mission to lead the transformation of dentistry through Sound Science. We are currently building a high-performance team with a passion for creativity and innovation that is committed to collaboration and integrity. We believe our success is based on developing disruptive technologies, and we strive to achieve excellence in our products and services by attracting energetic, entrepreneurial individuals who are committed to this vision. Applications accepted starting 11/17/25. The deadline to apply is subject to change. To apply, please submit your application through job boards, our company website, or call [phone] for assistance. The Senior Quality Engineer will be responsible for the effective design and manufacture of medical devices, compliance with internal procedures and external regulations, and the efficient execution of business activities thereto related. The Senior Quality Engineer will be expected to:

Requirements

• B.S. in Engineering, Life Science or related discipline required
• Minimum of 5 years work experience in a regulated industry required (medical device preferred)
• Minimum of 4 years work experience in quality engineering or quality assurance role
• Working knowledge of 21 CFR Part 820, ISO 13485 pertaining to class II/class IIb medical devices
• Demonstrated knowledge of statistical methods and principles
• Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers
• Ability to work independently and to carry out assignments to completion within parameters of instructions given, prescribed routines, and standard practices

Nice To Haves

• American Society of Quality Certified Quality Engineer (ASQ CQE) or Certified Medical Device Auditor (CMDA) a plus

Responsibilities

• Monitor and ensure compliance to internal quality system and external industry regulations
• Provide quality support to determine process improvements, lead investigations, root cause analyses, corrective action, implementation activities and interface with all cross functional departments and/or suppliers to increase product quality.
• Provide technical expertise regarding validations, verification and qualifications
• Perform investigations for NCMRs, SCARs, and CAPAs
• Participate in Risk Management activities ensuring compliance with ISO 14971, including but not limited to the completion of FMEAs, Risk Assessments, and Risk Management Plans/Reports.
• Develop and maintain inspection and quality control procedures
• Lead Supplier Management activities, including the execution of supplier qualifications and supplier audits
• Ensure compliance with design control procedures
• Maintain and develop procedures related to product realization and internal processes
• Manage and mentor quality technicians, providing guidance on quality control techniques, processes and procedures.
• Maintain compliance with Quality System procedures and company policies

Benefits

• Full-time employees are eligible for a comprehensive benefits package including medical, dental, vision, HSA, FSA, life, disability, 401(k), CA paid sick leave, and paid time off.
• Additional company-sponsored benefits, such as parental wage replacement and Employee Assistance Program (EAP), will be discussed upon hire.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Miscellaneous Manufacturing
• Number of Employees: 101-250 employees