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.
Responsibilities:
The QE Tech will be responsible performing complaint investigations on consumable and capital equipment, and the efficient execution of business activities thereto related. The QE Tech will be expected to:
Perform sample receiving from the field including decontamination and data entry
Initiate complaints and determination for Medical Device Reporting (MDR) after appropriate training received
Follow complaint handling process and associated Quality System procedures to perform tasks routinely
Complete complaint investigations, including sample evaluation, complaint record review, root cause analysis, following established job aid and procedures
Perform complaint analysis using Excel tools after proper training
Work on assignments with limited scope and detailed instruction under supervision
Maintenance of Complaints Lab including identify tool and coordinate equipment require calibration, cleanliness of workstation, organization of returned samples, purge of tested samples, inventory of testing supplies, etc.
Maintain compliance with Quality System procedures and company policies
Other duties as assigned by supervisor
Qualifications:
High School diploma or equivalent experience in a technical field
Zero (0) to two (2) years work experience in a regulated industry (medical device preferred)
Zero (0) to one (1) year work experience in quality engineering or quality assurance
Must be able to process and analyze data into meaningful information
Understanding of GMP and ISO quality systems
Excellent verbal communication skills, including effectively communicate with internal and external customers
Excellent computer proficiency (MS Office – Word, Excel and Outlook)
Ability to work under a fast-pace environment and high-level adherence to pre-established deadlines
Ability to work independently on routine work or follow prescribed instructions to complete new assignments
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 lift and carry up to 20 lbs
Must be able to talk, listen and speak clearly on telephone
Compensation:
We pay competitively. Base hourly rate range is $20.00 - $26.00. Other paid compensation and benefits may be available.
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.