Business Development, Operations, Policy and Planning, Six Sigma
Be at the forefront of bringing new and innovative medical devices into health care settings. Join the FDA’s growing Quality Management Team at FDA’s Center for Devices and Radiological Health (CDRH) and make a difference in healthcare. The Food and Drug Administration, Center for Devices and Radiologic Health (CDRH) Quality Management (QM) and Organizational Excellence (OE) Program, an ISO 9001:2015 certified organization, is looking for highly-qualified professionals committed to providing QM/OE experience, services and tools that will meet or exceed customer requirements.
The CDRH Quality Management and Organizational Excellence Program (CDRH QM/OE) Program, located in the Office of the Center Director works to achieve organizational excellence, implement quality management, promote efficiency and effectiveness, improve processes/products/services and achieve excellence in customer service across CDRH. Program activities support CDRH’s mission of providing the public access to safe, effective and high-medical devices and safe radiation-emitting products and vision of providing patients timely access to high-quality, safe and effective medical devices. The program also supports the Center’s 2018-2020 strategic priorities: Employee Engagement, Opportunity, and Success; Simplicity; and Collaborative Communities.
• Provides vision, leadership, and strategic direction for CDRH regarding quality management, and organizational excellence.
• Establishes and develops resources to facilitate implementation of quality management and organizational excellence across CDRH.
• Integrates applicable quality management and organizational excellence principles and best practices into CDRH key business processes.
• Establishes a foundation for quality, effectiveness, efficiency, and improvement for all CDRH products, services and business processes.
Working at the FDA
As an Engineer on CDRH’s Quality Management Team, you will be responsible for:
• Leading and/or facilitating the Center’s business processes improvement initiatives and projects, including those related to premarket review, surveillance and product compliance of medical devices.
• Monitoring and reviewing performance relative to quality objectives. Through timely analysis, adverse activities are identified, corrective actions are defined and implemented as determined to better fulfill the needs and expectations of our stakeholders in pursuit of delivering organizational excellence.
• Analyzing quality issues and contribute to the design and implementation of improvement to projects using quality management methodologies and tools to achieve results, including Lean and Six Sigma methods and tools.
• Developing practices, policies, and procedures designed to assure a Center policy and practice of continual quality assessment, management and improvement and to provide a means of detecting best practices and emerging quality issues.
• Providing expert information and consultation to other engineers, scientists, healthcare professionals, Center
representatives, and industry representatives on scientific, statistical, and regulatory aspects of the review process related to medical devices.
Successful candidates will be talented, innovative, out-of-the-box thinkers with experience that demonstrates capability providing technical expertise in one or more of the following quality management and organizational excellence focus areas: (1) expertise in training, facilitation/leading and execution of process improvements through data driven methodologies such as Lean Six Sigma; (2) Quality Management, QMS experience and training; and (3) a proven record of QM/OE knowledge and achievements (e.g., ASQ and/or Lean Six Sigma certifications and demonstrated improvements through LSS project leadership and facilitation). Candidates should have experience with:
• Providing engineering and analytical expertise executing and/or facilitating development and improvement of wide variety of regulatory, performance, and quality management areas.
• Evaluating the impact of procedures on scientific and regulatory policies and on overall activities and priorities of a quality management program.
• Applying engineering approaches to accomplish process evaluation, analyses and problem identification, problem resolution, and continuous improvement to matters related to regulatory, performance, and quality management.
Applicants must submit the following documents to: CDRH-OCD-Opportunities@fda.hhs.gov with the subject line of "OCD-QM-Engineer-001":
• Statement of interest
• A current resume or curriculum vitae
• Unofficial transcripts
Questions on qualification requirements and the selection process may be directed to CDRH-OCD-Opportunities@fda.hhs.gov.
Additional Salary Information: FDA position for this announcement range from GS11 - GS14
About FDA Center for Devices and Radiological Health
FDA/Center for Device and Radiological HealthMISSION:The mission of the Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. We assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. We provide consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products we oversee. We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.VISION:Patients in the U.S. have access to high-quality, safe, and effective medical devices of public health importance first in the world. The U.S. is the world’s leader in regulatory science, medical device innovation and manufacturing, and radiation-emitting product safety. U.S. post-market surveillance quickly identifies poorly performing devices, accurately characterizes real-world performance, and facilitates device approval or clearance. Devices are legally market...ed in the U.S. and remain safe, effective, and of high-quality. Consumers, patients, their caregivers, and providers have access to understandable science-based information about medical devices and use this information to make health care decisions.