Principal Quality Engineer

Sonendo, Inc. • Laguna Hills, CA

27d • $155,000 - $187,000

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.

Requirements

• Minimum B.S. in engineering, life science or related discipline.
• At least twelve (12) years work experience in a regulated industry (medical device preferred)
• At least five (5) years work experience in quality engineering or quality assurance.
• Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers
• Excellent computer proficiency (MS Office - Word, Excel and Outlook)
• Strong knowledge of Risk Management discipline and must be able to apply quality principles (GMPs, 21 CFR 820, ISO 14971:2012, IEC 60601, ISO 13485, EN 62304, and IEC 62366) to Design Controls
• Ability to lead multi-disciplinary teams
• Demonstrated knowledge of statistical methods and principles
• Ability to create and maintain project plans
• Must be able to work under pressure and meet deadlines, while maintaining a positive attitude and providing exemplary customer service
• Ability to work independently and to carry out assignments to completion within parameters of instructions given, prescribed routines, and standard practices
• 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).

Nice To Haves

• American Society of Quality Certified Quality Engineer (ASQ CQE) a plus

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.

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: Principal
• Industry: Miscellaneous Manufacturing
• Number of Employees: 101-250 employees