Quality Representative

Requisition Id 12096 

 

 

Overview: 

The Quality Assurance Division at Oak Ridge National Laboratory (ORNL) is seeking qualified applicants for the position as Quality Representative (QR). The QR works with the Group Lead (GL), customers, and other quality professionals to support/develop quality processes, tools and techniques, quality management systems, project/process improvements, strategic planning and performance metrics, and other quality-related initiatives to support the Metrology, Intercomparison Studies and Instrumentation and Services Groups in the Integrated Operations Support Division.

 

This position is responsible for providing support services by proactively deploying Laboratory policies, procedures, quality tools, and quality methodology in line organizations that meet the customers' requirements and achieves reliable and effective results supporting the customer's mission.

 

ORNL is the largest US Department of Energy science and energy laboratory, conducting basic and applied research to deliver transformative solutions to compelling problems in energy and security. Our diverse capabilities span a broad spectrum of scientific and engineering disciplines, enabling the Laboratory to explore fundamental science challenges and to carry out the research needed to accelerate the delivery of solutions to the marketplace.

 

 

Major Duties/Responsibilities:

• Maintaining, implementing, and monitoring the laboratory quality management system meeting the requirements of ISO-17025, 9001, 17043, or other standard.

• Developing and maintaining the laboratory quality manual and supplemental documents.

• Administering the computer and software quality assurance system.

• Assisting in the determination of the qualification of suppliers and subcontractors.

• Serving as the complaint system coordinator.

• Scheduling, performing, and coordinating internal audits and coordinating external audits and coordinating management reviews.

• Analyzing causes to resolve non-conforming work and any departures from documented policies and procedures.

• Ensuring adherence to applicable accreditation body program requirements such as ISO-9001, 17025 or 17043.

• Supports or leads continuous improvement initiatives in support of quality and performance management.

• Conducts assessments as well as conducts causal analyses as needed for identified events.

• Conducts investigations, corrective action verification and analysis and resolves quality problems, including occurrence reports, non-conformances, and PAAA and 10CFR851 non-compliances.

• Review audit and assessment results and identifies the associated severity/risk to ensure the appropriate level of action is planned and taken to eliminate non-conformance. Facilitates closure of concerns and commitments.

• Deliver ORNL’s mission by aligning behaviors, priorities, and interactions with our core values of Impact, Integrity, Teamwork, Safety, and Service. Promote diversity, equity, inclusion, and accessibility by fostering a respectful workplace – in how we treat one another, work together, and measure success.

 

Basic Qualifications:

• A Bachelor’s Degree in science, engineering, or a related field.

• A minimum of five years of quality experience

• A working knowledge of recognized Quality Standards such as NQA-1, ISO 9001,17025, cGMP and quality concepts.

 

Preferred Qualifications:

• Work experience and training in the field of metrologyquality assurance.

• Specific experiences with ISO/IEC 17025 - General requirements for the competence of testing and calibration laboratories, as well as the ISO 9000 - Quality Management System.

• Exceptional teamwork, statistical skills, and a positive, meticulous nature with a penchant for detail and precision are required attributes.

• Experience in leading developing, revising and maintaining procedures and completing technical reports.

• Ability to use analytical skills to identify resolution of issues. Ability to positively interact with all management and staff levels.

• Demonstrated track record of investigation analysis and problem solving is required.\

• Ability to grasp a diverse range of technical criteria and proactively recommend improvement opportunities that address organizational risks.

• Strong computer and organizational skills with the ability to multitask are required. Must have excellent verbal and written communication skills. 

• Strong analytical skills, project management, and customer ser