Principal Quality Engineer

Job Description

Job Description

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.

Essential Duties and Responsibilities :

• Participate in Risk Management activities. Provide technical expertise pertaining to the identification and mitigation of design and use risks.
• Develop and maintain Risk Management Files according to ISO 14971 and ensure Risk Management Files are updated per defined schedules and frequencies.
• Demonstrate ability to provide leadership to a team of direct reports within the Quality organization.
• Monitor and ensure compliance to internal Quality System and external industry regulations.
• Maintain current and develop new or revised internal processes, procedures and documentation related to all phases of product realization and related internal processes.
• Provide engineering support and guidance to other stakeholders with respect product and manufacturing / process improvements.
• Lead reviews of new or current Risk Reduction Assessments and root cause analyses for products and related processes; helping to ensure cross-functional implementation for risk reduction approaches and practices in all phases of product realization and related processes in compliance with ISO 14971 / ISO 24971.
• Provide guidance and assist Product Development with Design Control activities such as Design and Process Changes / Improvements, COGS reduction, risk assessment, protocol / report (V&V) writing, and data analysis.
• Support Customer Complaint, CAPA and NCMR functions such as root cause analysis and failure investigations, product dispositions, risk assessments, and write-up of associated reports.
• Lead MRB process, provide statistical trending and data-based outcome analyses for all critical components, nonconformance data from incoming and in-process activities, and generate regular and ad hoc reports for communication to department management and other Sonendo stakeholders.
• Maintain Inspection and Quality Control procedures.
• Take a lead role in Supplier Management QA activities including qualification, monitoring, problem resolution of and with critical component suppliers.
• Participate in internal audit activities, including planning, execution, and reporting of internal audits.
• Identify and make recommendations to Department Management for Quality System and product improvement opportunities.
• Perform related duties as assigned by supervisor.
• Maintain compliance with Quality System procedures and company policies.

Education and / or Work Experience Requirements :

Physical Requirements :

Compensation and Benefits :

We pay competitively. The base salary rate range for this position is $155,000 – $187,000, 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.