Company Information
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Company Name: ClearMask, LLC
Website: http://www.theclearmask.com

Job Information
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Job Title: Quality and Product Engineer
Job Type: Contract
Start Date: 02/22/2021
Start Date: Flexible
Job Description:
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.



Requirements:
Candidates must have the following qualifications:

-Bachelor’s degree in Engineering from an accredited university;
-Basic understanding of FDA regulations or ISO 13485 requirements for
document management;
-Experience in technical writing or documentation for technical content;
-Self-motivated and willing to learn, attention to detail, ability to take
initiative and follow through on projects; and
-Flexibility and adaptability to work in a fast-paced startup environment.

Candidates are preferred to have the following qualifications:

-At least 2 year of experience working in a medical device or similarly
regulated life science company;
-Experience working in quality assurance/control; and
-Experience with and working knowledge of eQMS software tools.

Strong candidates are:

-Highly attuned to detail.
-Well-versed in written communication in English.
-Task-oriented and able to follow-up and close-up tasks in a high pace work
environment.
-Able to take initiative and work independently, multitask, and shift
workload according to the department/team priorities.
-Highly organized with strong planning and organizational skills with
experience managing multiple priorities simultaneously.
-Extremely knowledgeable with Microsoft Office tools (e.g., Word, Excel,
PowerPoint) and PDF editor software.




Resume Information
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Applicants should submit the following:: Resume
Majors Desired:: Engineering
Degree levels accepted:: Associate, Bachelor

Application Information
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Apply online at:: https://www.theclearmask.com/careers