- Full Time
Occasional travel - You may be expected to travel for this position.
Relocation expenses reimbursed No
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 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.
All qualification requirements must be met by the closing date of the announcement.
This job does not have an education qualification requirement.
Veterans' Preference: If you are a veteran with preference eligibility and you are claiming 5-point veterans' preference, you must submit a copy of your DD-214 (Member Copy 4) or an official statement from your command if currently on active duty that certifies you are expected to be discharged or released from active duty service in the armed forces under honorable conditions not later than 120 days after the date the certification is signed. If you are claiming 10-point veterans' preference, in addition to the DD-214, you must also submit a Standard Form 15 (Application for 10-Point Veteran Preference) and the required supporting documents listed on that form. For more information on veterans' preference see http://www.fedshirevets.gov/.
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.
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 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
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 firstname.lastname@example.org. 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 job opportunity announcement closes, a review of your 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 responses when compared to your background information, you may be deemed ineligible or your score may be adjusted to more accurately reflect your skills and abilities. Please follow all instructions carefully. Errors or omissions may affect your eligibility.
Basis of Rating: Category rating procedures will be used to rate and rank candidates. The category assignment is a measure of the degree in which your background matches the competencies required for this position. Qualified candidates will be assigned to one of the following quality categories:
- Best Qualified- Applicants who have experience that is almost identical to those required by the position.
- Well Qualified- Applicants who have experience that is very similar to those required by the position.
- Qualified- Applicants who meet minimum qualification requirements, but do not identify any additional qualifying experience or skill.
The Category Rating Process does not add veteran's preference points but protects the rights of veterans by placing them ahead of non-preference eligibles within each category. Preference eligibles who meet the minimum qualification requirements and who have a compensable service-connected disability of at least 10 percent must be listed in the highest quality category (except in the case of scientific or professional positions at the GS-9 level or higher). Veteran preference eligibles will receive selection consideration before non-preference eligibles within each quality category.
Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics). You do not have to respond to the KSA's separately, but your resume should contain sufficient information to demonstrate possession of the Competencies/KSA's.
- 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/10169036 Read more Security clearance Public Trust - Background Investigation