Quality Assurance Specialist (MDR) at HEITECH SERVICES

, Maryland, United States -

Full Time

Start Date

Immediate

Expiry Date

30 Sep, 26

Salary

0.0

Posted On

02 Jul, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Control, Medical Device Reporting, Data Entry, Document Control, FOIA, Redaction, Microsoft Office, Analytical Skills, Medical Terminology, Database Querying, Technical Writing, Customer Service

Industry

IT System Data Services

Description

Description 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. 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. Essential Duties and Responsibilities Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 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 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. 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. 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. HeiTech Services is an Equal Opportunity Employer. We consider all qualified applicants without regard to race, color, religion, sex (including pregnancy, sexual orientation, and gender identity), national origin, age, disability, veteran status, or any other protected status under applicable law. If you require a reasonable accommodation during the application process, please contact us at HR@HeiTechServices.com. HeiTech Services may utilize technology-assisted tools, including artificial intelligence, to support the review of application materials. These tools are used to enhance efficiency; however, all hiring decisions are made by human reviewers in accordance with federal hiring guidelines.

Responsibilities

Ensure document quality controls are enforced for the FDA, specifically focusing on Medical Device Reporting (MDR). Responsibilities include performing quality checks for data entry, serving as a vocabulary specialist, and processing electronic and paper documents.