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Food and Drug Administration Consumer Safety Officer in Silver Spring, Maryland

Summary

This position is located in the Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Center for Devices and Radiological Health, Office of Product Evaluation and Quality, Office of In Vitro Diagnostics and Radiological Health, Division of Mammography Quality Standards (DMQS) which enforces the Mammography Quality Standards Act (MQSA) that requires mammography facilities across the nation meet uniform quality standards.

Responsibilities

Serve as a Consumer Safety Officer within DMQS, Program Management Branch (PMB), and has technical and authoritative expertise in mammography equipment, and regulatory knowledge of the Mammography Quality Standards Act (MQSA).

Serve as an expert advisor to the Office/Division, Field, State inspectors and facility personnel.

Provide authoritative guidance on MQSA issues to resolve issues and correct problems.

Serve as a point of contact for mammography facilities inspections and speaks for MQSA program on matters in the area involving regulatory responsibility for mammography facilities.

Keep fully abreast of new mammography modalities and communicate with mammography facilities about changes they must make to their processes in order to remain compliant with MQSA.

Requirements

Conditions of Employment

Qualifications

The position of Consumer Safety Officer falls under the 0696 occupational series. To qualify for this position at grade GS-12/13, you must meet the following: Basic Requirements A bachelor's or graduate/higher level degree in quality assurance or a related degree that included at least 30 semester hours in one or a combination of the following: consumer laws, biological sciences, food science, chemistry, pharmacy, physical sciences, food technology, nutrition, medical science, engineering, epidemiology, veterinary medical science, legal investigations, law enforcement, or related scientific fields that provided knowledge directly related to consumer safety officer work. The 30 semester hours may include up to 8 semester hours in statistics, or course work that included the principles, theory, or practical application of computers or computer programming. OR

Combination of education and experience--courses consisting of at least 30 semester hours in the fields of study described in the paragraph above, plus appropriate experience or additional education. Minimum Qualifications Specialized Experience. Specialized experience is experience that equipped the applicant with the particular knowledge, skills, and abilities to perform successfully the duties of the position, and that is typically in or related to the work of the position to be filled. GS-12: You must possess 1 year of specialized experience equivalent to the GS-11 in the Federal service that includes experience: assisting with researching, analyzing and interpreting laws, regulations and policies for mammography inspection programs; working with medical device safety laws such as the Food, Drug & Cosmetic Act (FD&C); and working with healthcare systems mammography facility quality control processes. GS-13: You must possess 1 year of specialized experience equivalent to the GS-12 in the Federal service that includes experience: researching, analyzing and interpreting laws, regulations and policies for mammography inspection programs; working with medical device safety laws such as the Food, Drug & Cosmetic Act (FD&C); working with healthcare systems mammography facility quality control processes; advising inspectors or regulated industry officials on mammography facilities; and developing policies for mammography facilities. Some federal jobs allow you to substitute your education for the required experience in order to qualify. For this job, you must meet the qualification requirement using experience alone--no substitution of education for experience is permitted. NOTE: It is your responsibility to ensure your responses and appropriate documentation is submitted prior to the closing date. To verify your application is complete, log into your USAJOBS account, https://my.usajobs.gov/Account/Login, select the Application Status link and then select the More Information link for this position. The Details page will display the status of your application, the documentation received and processed, and any correspondence the agency has sent related to this application. Be sure that any uploaded documents you provide in your application are free of document security or compression which might render the document unreadable by our system. IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. WE WILL NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. Qualifications are based on breadth/level of experience. In addition to describing duties performed, applicants must provide the exact dates of each period of employment (from MM/YY to MM/YY) and the number of hours worked per week if part time. As qualification determinations cannot be made when resumes do not include the required information, failure to provide this information may result in disqualification. Applicants are encouraged to use the USAJOBS Resume Builder to develop their federal resume. Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religious; spiritual; community, student, social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience.

Education

You MUST submit a transcript which includes a list of courses, grades, completion dates, and quarter or semester hours earned by the closing date of the announcement. Unofficial transcripts will be accepted in the application package. Official transcripts will be required prior to appointment if selected. Foreign Education:

If you are using education completed at foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program. If you have transferred educational credit from a foreign institution to one in the U.S., you must still show that your foreign education was evaluated by an organization recognized by the Department of Education, even if that foreign education was accepted as transfer credit by a domestic college or university. For more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation. SUBMITTING YOUR TRANSCRIPTS:

Positions which are scientific or technical in nature often have very specific educational requirements. A transcript is required to verify educational achievement. Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required. Even if you hold a similar position or are a current employee, you are not exempt from transcript requirements. Electronic Transcript Caution: If you have obtained your transcripts electronically, the file might contain security measures that could prevent our application system from reading the file. Therefore, you should consider asking the institution to provide the file in a non-secured electronic format. Alternatively, you could scan or take a photo of the printed copy of the transcript. If your uploaded transcript cannot be read by our system, you may receive consideration and credit for the information we can access. See the Application Manager Documentation for tips on submitting your paper-based documents.

Additional Information

For some advertisements, the Food & Drug Administration receives hundreds, even thousands, of applications from job-seekers. Because of this high level of interest in positions with the FDA, the agency reserves the option of setting an application number limit. When an application limit is set, USAJOBS will close the vacancy at 11:59 pm Eastern Time on either:

(A) the day the limit is reached,

-OR- (B) the pre-defined closing date of 04/16/2021, whichever comes first. If the limit is reached before 11:59 pm ET, all applications in excess of the limit will continue to be accepted until 11:59 pm ET. The application limit, if applicable, for this advertisement is: NO LIMIT For more information about announcement closing, see: https://www.usajobs.gov/Help/faq/job-announcement/expiration/ ADDITIONAL CONDITIONS OF EMPLOYMENT: If you are serving, or have served in the last 5 years (from 04/16/2021) as an Executive Branch political, Schedule C, or Non-career SES appointee, HHS/FDA may be required to obtain approval by the Office of Personnel Management (OPM) prior to beginning employment. You can find out if you have held one of these appointment types by looking at your Standard Form 50s in your Electronic Official Personnel Folder (eOPF), in Section 5 where the legal authorities are listed. If you have served or are currently serving, you must provide a copy of your SF-50, Notification of Personnel Action, documenting this appointment. In addition, you will be required to respond to the question in the assessment and certify your responses to the questionnaire. Political Appointee FAQ - OPM Incentives: Incentives may be authorized; however, this is contingent upon funds availability. If authorized, certain incentives will require you to sign a service agreement to remain in the Federal government for a period of up to 3 years. Note: This statement does not imply nor guarantee an incentive will be offered and paid. Incentives include the following: moving expenses, recruitment or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc. Special Appointing Authorities: If you are applying for eligibility based on a disability, veteran status, or under a career transition program, please pay careful attention to the Required Documents section for a detailed explanation of eligibility requirements to include supporting documentation. This position may require financial disclosure reporting and will be subject to FDA's prohibited financial interest regulation. If you are hired, you may be required to divest of certain financial interests. You are advised to seek additional information on this requirement from the hiring official before accepting any job offers. For more information please visit the FDA Ethics web page: https://www.fda.gov/about-fda/jobs-and-training-fda/ethics. Pre-Employment Physical: NO Drug Testing Requirement: NO License Requirement: NO Immunization Requirement: NO Mobility Agreement Required: NO Bargaining Unit Position: YES - 3591 National Treasury Employees Union (NTEU)

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