Quality Assurance Specialist II

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 3/9/2026. The deadline to apply is subject to change. To apply, please submit your application through job boards, our company website, or call (949) 766-3636 for assistance. Essential Duties and Responsibilities: The Quality Assurance Specialist II provides subject matter expertise with regards to the Sonendo quality system, ensuring compliance with internal procedures and external regulations, and ensuring efficient execution of business activities thereto related. The Quality Assurance Specialist II will be expected to perform the following in compliance with ISO 13485, 21 CFR 820, and SOR/98-282: * Maintain high ethical and professional compliance standards while promoting a Culture of Quality at all times * Coordinate and support Document Control and Training Management activities to ensure efficient workflow and timely processing of new, revised, and updated documents * Acts as eQMS (QCBD) Administrator by overseeing proper implementation & use of system * Work with RAQA management to maintain proper QCBD system configuration and validation * Maintain CAPA system, facilitate CAPA meetings, provide guidance on CAPA tracking/trending, root cause analysis and failure investigations, product dispositions, risk assessments, and write-up of associated reports * Maintain and support the Internal Audit program, including review of internal audit plans and reports and assisting audit team as needed * Facilitate Internal Audits * Participate in External Audits by overseeing & coordinating document retrieval as needed, lead backroom and scribe activities, as applicable and represent applicable quality system elements * Work with other departments as needed to ensure high-quality non-product software validations. * Lead various Quality System improvement initiatives * Perform annual External Standards review for new or revised standards. * Maintain compliance with company policies and procedures * Serve as a licensed Designated Representative in California for a Wholesaler/Non-Resident Wholesaler * Perform other quality and regulatory related duties as assigned Education and/or Work Experience Requirements: * Associates Degree or 2+ years in an accredited post-secondary degree program required. Bachelor's Degree preferred. * 2+ years' work experience in quality engineering or quality assurance. * Professional certification preferred (e.g. ISO13485 Lead Auditor, ASQ CQA). * Solid understanding of GMP/ISO Quality Systems and working knowledge of 21CFR820, ISO 13485 & SOR/98-282 * Excellent verbal communication skills, including ability to effectively communicate with internal audit stakeholders and external auditors. * Good technical writing skills sufficient to draft/review validation protocols/reports and QA investigation reports * Excellent computer proficiency (MS Office - Word, Excel and Outlook) * Must be able to work under pressure and meet deadlines, while maintaining a positive attitude and providing exemplary customer service * Ability to work independently with minimal supervision and to carry out assignments to completion Physical Requirements: * Ability to safely and successfully perform the essential job functions consistent with the ADA, FMLA and other federal, state and local standards, including meeting qualitative and/or quantitative productivity standards. * Ability to maintain regular, punctual attendance consistent with the ADA, FMLA and other federal, state and local standards * Must be able to safely move up to 25 lbs * The ability to communicate information and ideas so others will understand. Must be able to exchange accurate information in these situations. * Must be able to remain in a stationary position for 50% of the time. * Must be able to occasionally move about inside the office to access file cabinets, office machinery, etc. * The ability to observe details at close range (within a few feet of the observer). Compensation and Benefits: We pay competitively. The base salary range for this position is $74,000 - $95,000, depending on experience, qualifications, and location. Additional compensation such as annual or commission bonuses may be available. 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. Sonendo, Inc. fosters a collaborative, innovative workplace where every team member's ideas contribute to our success. We are an Equal Opportunity Employer. No recruiters, please.

Created: 2026-04-02