Director for Quality Management

Vacancy ID: 748618   Announcement Number: HHS-FDA-MP-12-748618   USAJOBS Control Number: 326653400

Occupational/Assessment Questions:

1. From the descriptions below, please choose the BEST answer that demonstrates your experience related to this position.

A. I have at least one year of specialized experience equivalent to the GS-14 grade level in the Federal service utilizing qualitative and/or quantitative methods for assessing and improving management, processes, and systems; applying laws, regulations, and policies associated with the regulation of medical products; overseeing the development, implementation, monitoring, and auditing of a quality management program; and providing advice and consultation on medical device and radiological health policies?
B. My experience is not reflected in choice A above.

In this part, you will respond to questions about experiences you have had that are related to the requirements of the job for which you are applying. Carefully review the response descriptions listed below. For each question or statement, select the one response description that best describes your experience, education, or training.

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 normally the person who is consulted by other workers to assist them in doing this task because of my expertise.

2. Provide strategic leadership and vision for the development and implementation of a quality management program.

3. Serve as the technical consultant and advisor to stakeholders on the development and implementation of quality management processes and policies.

4. Leading a team to ensure implementation of quality management efforts.

5. Develop and implement policies, practices, and procedures to strengthen quality management initiatives.

6. Identify problem areas or inherent weaknesses in work processes, procedures, information systems and content..

7. Develop indicators to provide objective evidence of the effectiveness of quality procedures and controls.

8. Plan and organize quality management audits.

9. Work with leadership to ensure issues are addressed.

10. Ensure audit process findings, issues, and non-compliances are addressed.

11. Oversee investigations and analyses of adverse quality trends or conditions and initiate corrective actions.