About the Team:

At HeiTech Services, our employees are our biggest assets.

HeiTech Services is dedicated to attracting highly skilled and motivated professionals. We value our employees. We offer our employees challenging opportunities that facilitate professional growth and development while also providing the support you need to succeed. We are committed to your success because we understand that our employees are the driving force behind HeiTech Services' continued growth.

Our mission is to help the Federal Government keep Americans safe.

About the Role:

HeiTech Services is seeking applicants for a Quality Assurance Specialist (QAS) position that will be responsible for ensuring document quality controls are enforced in support of the U.S. Food and Drug Administration (FDA). The primary functions of the QAS are to perform quality control checks for data entry and/or editor teams and ensure correctness, document control/processing, and the overall quality of deliverables within the scope of the work requirements. In addition, the QAS will function as a vocabulary specialist, having knowledge of and experience with medical devices and device terminology in a commercial environment or in a health information processing environment. While the QAS may be assigned to perform the functions above, they will also be cross trained to perform secondary duties according to project business needs. Work will be performed in Landover, MD.

Security Clearance:

Must possess (or be able to obtain) FDA public trust clearance.

Essential Duties and Responsibilities:

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Perform quality control of the data entry and editors to ensure correctness, document control & processing, and the overall quality of deliverables within the scope of the work requirements.
• Perform investigations for the resolution of problem reports using various desktop applications.
• Create and update excel spreadsheets to record the resolved problem reports.
• Process paper and electronic documents in accordance with current SOPs, as FDA transitions to electronic paperless environment.
• Redact patient and/or manufacturer confidential data.
• Daily use of office automation tools such as Microsoft Office and other common desktop applications.
• Make necessary changes to the work process, when requested.
• Provides quality control by reviewing completed work projects to ensure data accuracy, completeness, and timeliness.
• Function as a medical vocabulary specialist.

Skills and Abilities Required

• Technical background with knowledge of folder structure systems for electronic documents.
• Proficient with office automation tools such as Microsoft Office and other common desktop applications.
• Must have a combination of excellent analytical skills and a high attention to detail.
• Possess excellent verbal and written communication skills.
• Must be able to work in a fast-paced electronic production environment.
• Must have experience with reading and classifying scientific regulatory documents.
• Must have experience and working knowledge of the FOIA and redaction process.
• Must possess excellent customer service skills.
• Possess or be able to obtain/maintain a Government Public Trust Security Clearance.
• Must possess excellent computer skills and experience with the querying and use of databases.

Minimum Education and Experience Required:

• Bachelor's Degree, preferably in health or science related field AND/OR experience demonstrating an ability to use medical device terminology, understanding of policy issues, and experience with editing documents.
• Three (3) years related experience, with two (2) years direct experience processing documents and at least one (1) year of office, records, or computer experience.
• Must have knowledge and experience with medical devices and medical device terminology.
• Able to pass a typing test with a speed of 40 words per minute and no more than two errors.

Work Conditions:

• Work is primarily performed within a hybrid work environment with some work performed onsite and some telework.

HeiTech Services is an Equal Opportunity/Affirmative Action Employer. All qualified Applicants will receive consideration for employment without regard to race, color, national origin, sex, religion, age, sexual orientation, disability or veteran status.