Consumer Safety Officer (Medical Device/Radiological-MQSA), GS-696-13


Vacancy ID: 834574   Announcement Number: HHS-FDA-ORA-MP-13-834574   USAJOBS Control Number: 336759500

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 834574
1. Title of Job

Consumer Safety Officer (Medical Device/Radiological-MQSA), GS-696-13
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  a current Food and Drug Administration (FDA) employees with competitive status only?  Competitive status refers to employees who are serving on a career or career conditional appointment.


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 Competitive Merit Promotion
002 Reassignment/Non-Competitve Merit Promotion

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:


181580003 Fort Wayne, IN

22. Transition Assistance Plan

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

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. From the descriptions below, select the one which best describes your experience and meets the Additional Quaification 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 program procedures to determin compliance regarding Current Good Manufacturing Practices (CGMP).
B. I do not meet the requirements as described above.

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

A. I have successfully completed a full four year course of study at the 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 officer work. The 30 semester hours can include up to 8 semester hours in statistics, or course work that included the principle, theory, or practical application of comupters 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 hurs in the fields of study described in A above, plus appropriate experience or additional education.
C. I do not possess the experience and/or education described above.

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.

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

4. Responsible for understanding the organizational structures and interrlationships of compliance organizations and programs ensuring they relate to are of responsibility.

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

6. Ensures documentation and practices of firms are in compliance with laws, rules and regulations in protecting public health.

7. Remain current in the compliance area of medical device and diagnostics program in order to utilize and apply the latest technologies and skills when evaluating documents.

8. Makes recommendations to management officials as to whether or not a firm/individual involved in the production and control of all devices and device products is in compliance with GMP regulations.

9. Maintain crucial review of overall program to ensure applicable laws, guidance and policies are followed and implemented in accomplishing assigned tasks.

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

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

12. Reviews reports of inspections and investigations of violations to determine the sufficiency of evidence obtained.

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

14. Review and evaluate test methods and new automated methods of processing and analysis.

15. Conducts inspections and investigations of facilities where only limited guidance documents are avaiable or new regulations must be used in evaluating the industry.

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

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

18. Analyzes results, decides when an investigation is incomplete or what additional work my be required providing timely and accurate feedback to management.

19. Plans, conducts and directs highly technical, complex, and multiii-faceted inspections and in-depth investigations in the area of medical devices and device products (electrical, mechanical, in-vitro diagnostics and computer controlled).

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

21. Assists in or directly monitors compliance programs used of sample collection and/or inspection programs.

22. 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.

23. Makes recommendation to management officials when a manufacturer of medical devices is not incompliance with good manufacturing practices.

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

25. Meets with industry representatives exchanging information and providing advice and guidance regarding deficiencies.

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

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

28. Serves on task forces and study groups considering problems or directions in the are of medical device manufacturing.

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

30. Prepares reports, briefings and other background material concerning substantive issues, findings, conclusion and proposed solutions keeping appropriate staff involved at key decision points.

31. Evaluates and makes recommendations on necessary regulatory action preparing reply stating Agency concerns.

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

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