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[QA/QC Manager] Technical QA Specialist

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Major Duties/Responsibilities:
� Work independently to provide quality assurance support for implementation of a graded approach to quality requirements within an Laboratory research environment, with increasing rigor as project progresses through construction to commission activities.
� Identify and understand customer needs while influencing the prioritization and development of quality initiatives.
� Provide guidance and support development of project plans, checklists, procedures, and guidelines for efficient and effective deployment of management systems and organizations supported.
� Provides leadership and support in appropriately applying quality standards and requirements based on the needs of sponsors and internal customer organizations, programs, projects and activities.
� Using the graded approach as described in the ORNL QA Program Description, DOE Order 414.1D, and quality standards including ASME NQA-1-2008/9a and ISO 9001:2015, reviews project, program, and line management needs and provide quality support with a graded approach based on the risk associated with the wide range of technical activities and the rigor required by the needs of myriad of sponsors.
� Assists in the management determination of need for development of technical guidelines, procedures, related work controlling documents and develops project quality plans, checklists, procedures, and guidance supporting successful quality program implementation.
� Provide quality planning assistance for various tasks, projects, procurements, work evolutions; provide assessments of work in progress, including document reviews against specifications.
� Verifies critical characteristics for acceptance of Safety Affecting Items identified prior to procurement
� Participtation on the Design Change Control Board, Baseline Change Control Board, all types of Configuration Management Changes, and Support ORNL teams in providing objective evidence of the effectiveness of ORNL�s quality program to sponsors and their assessors.
� Provides incisive QA training based on organization, program, project, and related line customer needs.
� Understanding of PAAA requirements and use of Graded Approach to Quality Programs
� Reviews Suppliers proposals for compliance with quality requirements
� Makes quality category determinations in coordination with Engineering
� Serves as the interface coordinator with FFESD Software Quality Assurance (SQA) point of contact to assist staff in implementation of the Laboratory�s SQA program
� Reviews procurement orders, requisitions, product specifications, design specifications, and other documents for incorporation of appropriate quality controls, utilizing the Laboratory�s Quality Significant Review process.
� Attends Supplier Quality Weekly status meetings to address QA concerns and monitor Suppliers
� Conduct supplier evaluations and perform oversight of inspection of fabricated items and assemblies to ensure conformance with established performance criteria, including NQA-1; may include source inspections or witnessing of NDE of critical components and assemblies.
� Conduct material receiving inspection on safety related and non-safety related materials.
� Provides staff with guidance concerning pre/post-procurement receipt of items, equipment, and services.
� Assists in implementation of nonconformance processing and in the development of effective corrective actions using the ORNL Assessments and Commitments Tracking System.
� Works with the directorate-level Quality Manager to establish quality program priorities and needs.
� Establishes relationships and works effectively with both external and internal customers to meet goals and assess customer satisfaction.
� Builds and develops strong relationships with peers and others to exchange feedback on issues or concerns.
� Performs surveillances and management activity assessments
� Serves on internal design reviews in preparations for operations and readiness demonstration activities

Basic Qualifications:
� A Bachelor�s Degree in science, engineering, or a related field.
� A minimum of five years of quality assurance experience
� A working knowledge of recognized Quality Standards such as NQA-1, ISO 9001, cGMP and quality concepts.

Preferred Qualifications:
� Excellent written and oral communication skills.
� Motivated self-starter with the ability to work independently and to participate creatively in collaborative teams across the laboratory.
� Ability to function well in a fast-paced research environment, set priorities to accomplish multiple tasks within deadlines, and adapt to ever changing needs Knowledge and experience in validating implementation of quality assurance programs in an R&D environment.
� Experience as a critique facilitator and root cause analyst or the ability to obtain qualifications as an ORNL Critique Facilitator and ORNL Root Cause Analyst.
� Ability to read and interpret design drawings.
� A demonstrated track record of investigation analysis and problem solving.
� Strong computer, organizational, verbal and written communication skills.
� Strong analytical skills; customer service experience; and the ability to interpret, communicate, and implement complex instructions.
� This position may require some level of travel.

Special Requirements:

Q clearance: This position requires the ability to obtain and maintain a clearance from the Department of Energy. As such, this position is a Workplace Substance Abuse (WSAP) testing designated position. WSAP positions require passing a pre-placement drug test and participation in an ongoing random drug testing program.


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