Job details

Principal Quality Engineer

Overview:

Sonendo, 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.

This Principal Quality Engineer is highly visible opportunity for a Subject Matter Expert in Quality Operations. You will join our mission in building a quality culture at Sonendo. Our leaders are looking for this quality ambassador to lead employee training focused on quality operations initiatives. Your legacy will be made by delivering products of high quality standards that will help transform dentistry.

Responsibilities:

Demonstrated 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
Oversee and help ensure proper implementation and reporting of regular sterilization cycle dose auditing and regular bioburden testing of product which utilizes Gamma Irradiation
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
Maintain Equipment Calibration and preventive maintenance including requisition and qualification of existing and new equipment
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

Qualifications:

Minimum B.S. in engineering, life science or related discipline. American Society of Quality Certified Quality Engineer (ASQ CQE) a plus
At least twelve (12) years work experience in a regulated industry (medical device preferred)
At least twelve (12) 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

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Position is primarily sedentary, and employee may be required to sit for extended periods of time. Standing, walking and meeting activities are required frequently throughout the workday. Employee must be able to process paperwork and utilize office equipment (including personal computer, phone, copiers, etc.). A large portion of the day is spent communicating orally in person and by phone. Normal sight or corrected vision is required to read documents and use standard computer terminals. Some light lifting may be occasionally required.Sonendo offers a competitive benefits package and a collaborative, motivating work environment where you will be encouraged to innovate continuously; This is a place where you will be encouraged to actively participate, and your ideas can have a direct impact on the success of the organization. If you are interested in applying for this position, please apply online.

Additional Information

Sonendo offers a competitive benefits package and a collaborative, motivating work environment where you will be encouraged to innovate continuously; This is a place where you will be encouraged to actively participate, and your ideas can have a direct impact on the success of the organization. If you are interested in applying for this position, please apply online.

No recruiters, please.

Sonendo, Inc. is an Equal Opportunity Employer

Compensation:

We pay competitively. Base salary range is $131,000 - $177,000. Other paid compensation and benefits may be available.

Sonendo Glassdoor Company Review

3.5