CONSUMER SAFETY OFFICER (Medical Device/Radiological-MQSA)


Vacancy ID: 766200   Announcement Number: HHS-FDA-ORA-MP-13-766200   USAJOBS Control Number: 328801500

Social Security Number

Enter your Social Security Number in the space indicated. Your Social Security Number is requested under the authority of Executive Order 9397 to uniquely identify your records from those of other applicants who may have the same name.  As allowed by law or Presidential directive, your Social Security Number is used to seek information about you from employers, schools, banks and others who may know you. Providing your Social Security Number is voluntary, however we can not process your application without it.


Vacancy Identification Number

Enter 766200
1. Title of Job

CONSUMER SAFETY OFFICER (Medical Device/Radiological-MQSA)
2. Biographic Data

3. E-Mail Address

4. Work Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

5. Employment Availability

Are you an ICTAP Eligible?

For information on how to apply as an ICTAP eligible see http://opm.gov/rif/employee_guides/career_transition.asp#ictap.  To be well-qualified and exercise selection priority for this vacancy, displaced Federal employees must be rated at 85.0 or above on the rating criteria for this position.


Are you eligible for Indian preference as defined by the Department of the Interior (DOI) and as evidenced by appropriate Bureau of Indian Affairs (BIA) authorized certification?


Are you eligible for preference based on being a Public Law 94-437 Indian Health Service Scholarship recipient? For more information, please click here.    


Are you eligible for the Federal Employment Program for Persons with Disabilities? (For information on Schedule A appointments, see the OPM website.)    


Are you a PHS Commissioned Officer (This includes active duty officers, inactive reserve officers, and applicants who have been approved for commissioning in the USPHS Commissioned Corps)?


Are you eligible for noncompetitive appointment?
This includes applicants who are eligible for special or noncompetitive appointment authorities such as 30% or more compensable disabled veterans, persons with disabilities and PHS Commissioned Corps Officers.  This also includes applicants who meet the qualifications for this position and who have previously held, or currently hold, a Federal position at the grade of this position.


6. Citizenship

Are you a citizen of the United States?
7. Background Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

8. Other Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

9. Languages

If you are applying by the OPM Form 1203-FX, leave this section blank.

10. Lowest Grade

Enter the lowest grade level that you will accept for this position. The lowest grade for this position is 13.


13

11. Miscellaneous Information

If you are a male at least 18 years of age, born after December 31, 1959, have you registered with the Selective Service System?


01 Yes
02 No
03 Not Applicable

12. Special Knowledge

If you are applying by the OPM Form 1203-FX, leave this section blank.

13. Test Location

If you are applying by the OPM Form 1203-FX, leave this section blank.

14. Veteran Preference Claim

15. Dates of Active Duty - Military Service

16. Availability Date

17. Service Computation Date

If you are applying by the OPM Form 1203-FX, leave this section blank.

18. Other Date Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

19. Job Preference

If you are applying by the OPM Form 1203-FX, leave this section blank.

20. Occupational Specialties

Select/enter at least one occupational specialty. The specialty code for this position is:


001 Medical Device/Radiological-MQSA-Competitive
002 Medical Device/Radological-MQSA Non-Competitive

21. Geographic Availability

Select/enter at least one geographic location in which you are interested and will accept employment. The location code for this position is:


130280121 Atlanta, GA

22. Transition Assistance Plan

23. Job Related Experience

If you are applying by the OPM Form 1203-FX, leave this section blank.

24. Personal Background Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

25. Occupational/Assessment Questions:

1.  Are you a current Career/Career conditional employee of the Food and Drug Administration, Office of Regulatory Affairs or an FDA ORA Commissioned Corps officer?

A. YES
B. NO

2. From the descriptions below, select the one which best describes your experience and meets the Additional Qualifications Requirements for Consumer Safety Officer (Medical Device/Radiological-MQSA), GS-0696-13.

A. I have one year of specialized experience equivalent to the GS-12 grade level in the Federal service that includes investigation and inspectional work involved in the medical devices (electrical, mechanical, in-vitro diagnostics and computer controlled) and diagnostic programs procedures to determine compliance regarding Current Good Manufacturing Practices (CGMP).
B. I do not meet the requirements as described above.

3. From the description below, select the one which best describes your education and/or experience and meets the Basic Qualifications Requirements for Consumer Safety Officer (Medical Device/Radiological-MQSA), GS-0696-13.

A. I have successfully completed a full four year course of study at an accredited college or university leading to a bachelor's or higher degree that included at least 30 semester hours in one or a combination of the following: biological sciences, chemistry, pharmacy, physical sciences, food technology, nutrition, medical science, engineering, epidemiology, veterinary medical science, or related scientific fields that provided knowledge directly related to consumer safety offer work. The 30 semester hours can include up to 8 semester hours in statistics, or course work that included the principles, theory, or practical application of computers or computer programming.
B. I have a combination of education and experience which includes course work equivalent to a major as shown in A above, including courses consisting of at least 30 semester hours in the fields of study described in A above, plus appropriate experience or additional education.
C. I do not posses the experience and/or education described above.

4. . Do you meet the time-in-grade requirement of 52 weeks at the GS-12 grade level.

A. YES
B. NO

INSTRUCTIONS: For each task in the following group, choose the statement from the list below that best describes your experience and/or training. Darken the oval corresponding to that statement in Section 25 of the Qualifications and Availability Form C. Please select only one letter for each item.

A- I have not had education, training or experience in performing this task.
B- I have had education or training in performing the task, but have not yet performed it on the job.
C- I have performed this task on the job. My work on this task was monitored closely by a supervisor or senior employee to ensure compliance with proper procedures.
D- I have performed this task as a regular part of a job. I have performed it independently and normally without review by a supervisor or senior employee.
E- I am considered an expert in performing this task. I have supervised performance of this task or am normally the person who is consulted by other workers to assist them in doing this task because of my expertise.

5. Serves as a principal source of expertise providing extensive advisory, liaison and consultative services for medical device programs to regulated industries, State agencies, other Federal agencies and agency management advising on new advances in technology related to medical device products, new programs, laws and regulations, significant court decisions and any new trends or findings involving medical device products.

For each task in the following group, choose the statement from the list below that best describes your experience and/or training. Darken the oval corresponding to that statement in Section 25 of the Qualifications and Availability Form C. Please select only one letter for each item.

A- I have not had education, training or experience in performing this task.
B- I have had education or training in performing the task, but have not yet performed it on the job.
C- I have performed this task on the job. My work on this task was monitored closely by a supervisor or senior employee to ensure compliance with proper procedures.
D- I have performed this task as a regular part of a job. I have performed it independently and normally without review by a supervisor or senior employee.
E- I am considered an expert in performing this task. I have supervised performance of this task or am normally the person who is consulted by other workers to assist them in doing this task because of my expertise.

6. Responsible for interpretation and application of the Food, Drug and Cosmetic Act, Current Good Manufacturing Practices (CGMP) and related industry practices and regulations ensuring accuracy and completeness of objectives.  .

7. Responsible for understanding the organizational structures and interrelationships of compliance organizations and programs ensuring they relate to area of responsibility.

8. Formulates recommendations based on background and understanding of policies, regulations, procedures and information.

9. Review reports of inspections and investigations for violations to determine the sufficiency of the evidence obtained.

10. Develops and interprets established operating policies and procedures in order to formulate and recommend plans, leadership, guidance and program strategies.

11. Manages the review of previously approved products, determining whether they should continue to be permitted in light of current scientific safety criteria and recommending a course of action if needed. 

12. Acts upon full range of violations within the area of expertise, including emergency situations, ensuring violation is corrected. 

13. Advises on new advances in technology related to blood and blood products, new programs, laws and regulations, significant court decisions and any new trends or scientific findings involving biological products. 

14. Develop and interpret established operating policies and procedures in order to formulate and recommend plans, leadership, guidance and program strategies.

15. Makes recommendations to  management officials when a manufacturer of medical devices is not in compliance with good manufacturing practices.

16. Advises on new advances in technology regulated to medical device products, new programs, laws and regulations, significant court decisions, and new trends or scientific findings involving drug products.

17. Assists in long term investigations and grand juries, and may be designated as the lead Agency representative of mulit-agency/multi-organization investigations with limited oversight.

18. Conducts more complex, technical investigations and inspections of establishments involving the production and control of all devices and device products, preparing proposed or final endorsements.

19. Assists in long term investigations, grand juries, or multi-organization investigations with limited oversight directly monitoring or managing compliance programs for sample collection or inspection programs.

20. Performs investigations involving complaints of injury or death, requiring special coordination and a high degree of insight, planning and deciding and directing the investigation.

21. Plans, conducts and directs highly technical, complex and multi-faceted inspections and in-depth investigations in the area of medical devices and device products (electrical, mechanical, in-vitro diagnostics and computer controlled)  where sometimes only limited guidance documents are available or new regulations must be used.

22. Conducts inspections of both domestic and international medical device establishments serving as a member of the international inspection cadre.

23. Skilled in interviewing and criminal investigations  techniques making recommendations to higher management officials whether or not an establishment is in violation of the CGMP..

24. Provides extensive advisory, liaison and consultative services for the medical device programs to regulated industries, State agencies and other Federal agencies and management.

25. Develop and maintain effective communication with regulated industry, consumer groups and the general public.

26. Handles hostile or uncooperative industrial officials with tact and firmness to obtain information needed.

27. Serves as an expert witness in court cases dealing with regulated products in areas involving the production and control of all devices and device products.

28. Prepares memoranda, briefings and other background material concerning substantive issues, findings, conclusions and proposed solutions to keep management and appropriate staff involved at key decision points.

29. Prepares proposed or final EIR endorsements with reports developed and accepted with little or no review or oversight.

30. Develops and implements formal training programs for personnel, industry and state/local officials, providing technical expertise as needed.