Quality Assurance Specialist (MDR)

HEITECH SERVICES•Landover, MD

11h•Hybrid

About The Position

This position is responsible for ensuring the document quality controls are enforced in support of our customer, the Food and Drug Administration (FDA). There are two primary functions to which the Quality Assurance Specialists (Medical Device Reporting - MDR) are assigned: Performing all quality control checks for data entry teams and serve as a medical device vocabulary specialist. While Quality Assurance Specialists may be assigned to perform these primary functions shown above, they will also be cross-trained to perform secondary duties according to business need. Security Clearance: Must possess or be able to obtain a Public Trust Clearance. Location: This position requires onsite attendance in the office (Landover, MD) during the training period. After successful completion of training, the role may be eligible for remote or hybrid work arrangements.

Requirements

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 attention to detail.
Possess excellent verbal and written communication skills.
Must be able to work in a fast-paced paper and 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.
Attention to detail is MANDATORY.
Shall possess excellent computer skills and experience with the querying and use of databases.
Ability to type 40 words per minute with no more than two errors.

Nice To Haves

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.

Responsibilities

Perform quality control and control of the data entry and correctness, document control & processing, and the overall quality of the performance of the scope of work.
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 away from a total paper environment to an electronic paperless environment.
Redact patient and/or manufacturer 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 the vocabulary specialist.