Quality Assurance Specialist (MDR)

This position is responsible for ensuring the document quality controls are enforced in support of the Food and Drug Administration (FDA). The primary functions of the Quality Assurance Specialists (QAS) is to perform 100% 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.

Essential Duties and Responsibilities

• 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 moves into a 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.

Work Conditions:

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

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 off policy issues, and experience in performing editing of 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.
• Ability to type 40 words per minute with no more than two errors.

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

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Retirement plan
• Vision insurance

Experience level:

• 3 years

Schedule:

• Monday to Friday

Work setting:

• In-person
• Office

Experience:

• Document processing: 3 years (Required)

Ability to Commute:

• Hyattsville, MD 20785 (Required)

Ability to Relocate:

• Hyattsville, MD 20785: Relocate before starting work (Required)

Work Location: In person