Occasional travel - You may be expected to travel for this position.
Relocation expenses reimbursed No
Time-in-Grade: One year at the GS-13 level is required to meet the time-in-grade requirements for the GS-14 level.Under competitive merit promotion procedures, any individual who is currently holding, or who has held within the previous 52 weeks, a General Schedule position under a non-temporary appointment in the competitive or excepted service, must meet "time-in-grade" requirements (have served 52 weeks at the next lower grade of the grade for which you are applying). Time-In-Grade requirements also apply to current employees applying for a Veterans Employment Opportunities Act of 1998 (VEOA) appointment. NOTE: You must provide a copy of your SF-50 (you may need to submit more than one), "Notice of Personnel Action" that indicates proof of status and time-in-grade eligibility. The SF-50 must include your position, title, series, grade, step, tenure, type of service (Competitive or Excepted) and career status (career or career-conditional).
For GS-14: At least one year of specialized experience, equivalent to the GS-13 level in the Federal service, interpreting quality management systems principles, policies or regulations, and its application on the evaluation of medical devices or scientific products to provide guidance for program operations; conducting studies to evaluate the efficiency and effectiveness of programs; developing quality systems policies and procedures for use by multiple scientific programs in the evaluation, development or review of medical devices; implementing a quality information management system to collect and evaluate data on program performance; and collaborating with key stakeholders, scientists, or industry officials to accept recommendations and coordinate projects.
(This experience must be clearly demonstrated in your resume).
IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. WE MAY NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. If your resume does not support your questionnaire answers, we will not allow credit for your response(s).
NOTE: 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; community; student; social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to gain employment. You will receive credit for all qualifying experience, including volunteer experience. If such experience is on a part-time basis, you must provide the average number of hours worked per week as well as the beginning and ending dates of the experience so it can be fully credited.
Documenting experience: In accordance with Office of Personnel Management policy, federal employees are assumed to have gained experience by performing duties and responsibilities appropriate for their official series and grade level as described in their position description. Experience that would not normally be part of the employee's position is creditable, however, when documented by satisfactory evidence, such as a signed memorandum from the employee's supervisor or an SF-50 or SF-52 documenting an official detail or other official assignment. The documentation must indicate whether the duties were performed full time or, if part time, the percentage of times the other duties were performed. It is expected that this documentation is included in the employee's official personnel record. In order to receive credit for experience in your resume that is not within the official series and grade level of your official position, you must provide a copy of the appropriate documentation of such experience as indicated above.
This job does not have an education qualification requirement.
Political Appointment: If you are serving, or have served in the last 5 years (from the close of this announcement) 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 questionnaire and certify your responses.
Veterans Employment Opportunities Act (VEOA): To be eligible for a VEOA appointment, the veteran must 1) be a preference eligible; or 2) be a veteran separated after 3 or more years of continuous active service performed under honorable conditions (you must submit a DD214-member copy 4).
Career Transition Program: This program applies to Federal service employees whose positions have been deemed surplus or no longer needed, or employees who have been involuntarily separated from a Federal service position within the competitive service. To receive selection priority for this position, you must: 1) meet eligibility criteria for CTAP or ICTAP; 2) be rated well-qualified (score an 85 or higher) for the position; and 3) submit the appropriate documentation to support your CTAP or ICTAP eligibility. Well-Qualified includes those applicants whose knowledge, skills, and abilities clearly exceed the minimum qualification requirements for the position. For information on eligibility criteria and required documentation, go to: http://www.opm.gov/rif/employee_guides/career_transition.asp
Noncompetitive Appointment Authorities: The following links contain information on the eligibility requirements to be considered under a noncompetitive appointing authority:
Persons with Disabilities-Schedule A
Special Hiring Authorities for Veterans
Special Hiring Authority for Certain Military Spouses
Other Special Appointment Authorities
Selective Service: Males born after 12/31/59 must be registered or exempt from Selective Service (see http://www.sss.gov/).
Reasonable Accommodation: This agency provides reasonable accommodation to applicants with disabilities. If you need a reasonable accommodation for any part of the application and hiring process, please contact the Bethesda Customer HelpDesk at (888) 478-4340; TTY/TDD: (800) 877-8339; or by email email@example.com. The decision on granting reasonable accommodation will be made on a case-by-case basis.
You are encouraged to apply online. If you are unable to apply online or need to fax a document you do not have in electronic form, view the following link for information regarding an Alternate Application.
You will be evaluated for this job based on how well you meet the qualifications above.
Once the application process is complete, a review of the resume and supporting documentation will be made and compared against your responses to the assessment questionnaire to determine if you are qualified for this job. If, after reviewing your resume and or supporting documentation, a determination is made that you have inflated your qualifications and or experience, you may lose consideration for this position. Please follow all instructions carefully. Errors or omissions may affect your eligibility.
For Competitive Merit Promotion and Veterans Employment Opportunities Act (VEOA) Applicants: The highest rated candidates will be referred to the hiring agency.
For Noncompetitive Appointment Eligibles: All qualified candidates will be referred to the hiring agency.
Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics).
- Information Management
- Oral Communication
- Planning and Evaluating
- Technical Competence
If you are referred to the hiring manager for consideration, you may be further evaluated based on an interview; review of requested work samples, writing samples, most recent performance evaluation(s), or professional references; or results of an oral presentation or work-related test. Failure to comply with any of the additional assessment requirements will result in removal from further consideration. These assessment methods/tools may also be listed under Key Requirements.
To preview the assessment questionnaire, click the following link: https://apply.usastaffing.gov/ViewQuestionnaire/10167842 Read more Security clearance Public Trust - Background Investigation