The Quality and Product Engineer will be responsible for ensuring that ClearMask’s products meet applicable regulatory requirements prior to and during commercialization by assisting with the operation and maintenance of the Quality System. This responsibility includes ensuring compliance with all aspects of the Quality System (e.g., document controls, supplier management controls, CAPA, and complaint handling), which includes planning, conducting, and monitoring product quality and the Quality System.

The Quality and Product Engineer works primarily with the Quality and Engineering teams, and will also have the opportunity to assist with product development and manufacturing. The candidate may be located anywhere in the United States, must be eligible to work in the U.S., and will work full-time, 40 hours/week, Eastern Standard Time.

Job duties may include:

-Reviewing new or revised Quality Documents and Quality
-Records for compliance to established FDA standards to ensure all documentation meets applicable regulatory requirements before processing documents in the Company’s document and record control workflows;
-Working with a multi-disciplinary team, obtaining work-in-progress technical documents (requirements and specifications), and finalizing documentation into formal and controlled design documentation;
-Working with Engineering to develop test plans, create test protocols, conduct testing, finalize test reports, and report test results and conclusions;
-Participating in the issue resolution or design improvement processes;
-Work with the Company’s contract manufacturers on creating, distributing, collecting, or reconciling the product design and production documents and records;
-Planning and conducting data analysis regarding product quality and Quality System processes;
-Assist with manufacturing, product development, and engineering matters as needed; and
-Other duties as required by the Quality and Product Engineering functions of the Company.

The ClearMask™ brand is the first fully transparent, FDA-cleared mask with maximum clarity and comfort: making connections more human and providing clear communication for all. Started 3 years ago by four Johns Hopkins students and alumni, the company has grown from an idea to a thriving business. We are proud to increase accessibility in healthcare and beyond by allowing view of the face while providing assured protection. More at theclearmask.com.