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Senior Quality Engineer

4 months ago

Richland, United States Pacific Northwest National Laboratory Full time

Responsibilities



The primary purpose of the Quality Engineer (QE) role at PNNL is to support Science and Technology (S&T) projects in establishing effective quality assurance processes and practices – with the overall impact of mitigating risk and ensuring compliance while striving for increased efficiency and effectiveness of project execution. The QE is the primary deployed resource for the Quality Division, working directly with Quality Managers, Project Managers, and project staff to achieve this impact. The QE is responsible and accountable for delivering (i.e., planning, implementing, and assuring effectiveness) all elements of the PNNL's Quality Management Program and compliance with project-specific requirements.

Overall, the successful Quality Engineer will have a demonstrated track record of leadership and broad-based exposure to quality-related techniques and methodologies. 

Implement and evaluate the QA program/procedures/processes across Pacific Northwest National Laboratory (PNNL) R&D projects and Facilities & Infrastructure Operations. Provide QA/QC support to design and system engineers in the development and review of engineering design media for the facility. Assist in the review and approval of facility procurement documents, including performance of technical evaluations. Assist design and system engineers in the development and completion of commercial grade dedication plans. Develop and maintain the facility quality program procedures and processes. Perform receipt, source, in-process, and final inspections for facility systems, structures, and components. Plan, schedule, and perform compliance and performance-based assessments and surveillance. Assist in the performance of Management and Independent assessments. Responsible for identifying and reporting non-conformance and conditions adverse to quality and follows up to ensure completion.
Qualifications

Minimum Qualification:

BS/BA and 7 years of relevant experience -OR- MS/MA or higher and 5 years of relevant experience.

Preferred Qualifications:

Professional license and/or certification in a quality, quality assurance or assurance-related area preferred. Experience working in a highly regulated environment/industry with a robust Environment, Health, Safety, and Quality (EHS&Q) culture. (e.g. nuclear, oil and gas, transportation, medical, pharmaceutical, aerospace, food, etc.). Experience and practice with any of the following: NQA-1, DOE Order 414.1D, 10 CFR 50 App B, 10 CFR Part 21, 10 CFR Part 71, and/or 10 CFR 830 requirements. Experience in quality program development, maintenance and implementation. Auditing and/or surveillance background including on-site fabrication surveillance and reporting experience. NQA-1 Lead auditor certification or the ability to attain a lead auditor certification, is strongly desired. (Note: In-depth auditing experience in rigorous standards such as AS9100 will also be considered). Experience working with or managing suppliers in manufacturing/fabrication environments, with an understanding of surveillance, process qualifications, welding, inspections, QC data package reviews, etc. Knowledge and experience of the Commercial-Grade Dedication (CGD) process including developing CGD plans while leading the necessary R2A2s of other team players (i.e. design engineers, process engineers, suppliers, etc.) to effectively deliver commercial-grade items under the applicable requirements. Fundamental background in the basics of Software Quality Assurance (SQA) with an emphasis in safety-related software. In lieu of, an interest to be trained in SQA. Technical writing and composition skills matching processes to procedures. Experience with drawings and inspection design, including Geometric Dimensioning and Tolerancing (GD&T). Fundamental background in process capability studies, control, improvement, and the benefits of collecting data in decision making. In lieu of, an interest in being trained in Lean/Six Sigma methodologies, process modeling, trending, etc. Apparent Cause Analysis (ACA), Root Cause Analysis (RCA) and the modeling of sustainable solutions.

Highly desired Knowledge, Skills, and Abilities (KSAs) and experience, but not required to apply:

Significant experience in a construction operation, manufacturing and/or fabrication environment that is highly regulated (i.e. nuclear, aviation, medical device, etc.) with a strong understanding of how to lead Quality Assurance and Quality Control of a product and/or program. Experience in providing oversight of specific QA plans, supplier evaluation scheduling and coordination, pre-evaluation, notification, reporting, corrective action, and documentation. Confidence to ensure quality assurance results, materials, processes, and final products meet quality specifications and are completed according to established requirements. Strong capability to review and approve inspection reports including evaluating and closing non-conformance reports.
Familiarity in one or all of the following Non-Destructive Testing (NDT) elements: designing and qualifying a process, administering tests, procedural writing and surveillances. Experience performing Non-Destructive Examination: LT, RT, UT, PT, etc. Comfortable directing and assisting other quality engineers, quality specialists, and technical specialists in the planning, conduct, and reporting of vendor and internal independent assessments, surveillances, and audits. Confidence to independently perform a surveillance and when required, to be part of an audit team or possibly lead a team of auditors. A holder or past holder of any of the following certifications/license: ASQ CQE, CSQE, CQA, ASNT NDE (Level II or III), AWS CWI, PE License, Lean Six Sigma Black Belt.
Hazardous Working Conditions/Environment

Not Applicable


Additional Information

This position requires the ability to obtain and maintain a federal security clearance. 

Requirements:

U.S. Citizenship

Background Investigation: Applicants selected will be subject to a Federal background investigation and must meet eligibility requirements for access to classified matter in accordance with 10 CFR 710, Appendix B.

Drug Testing: All Security Clearance positions are Testing Designated Positions, which means that the candidate selected is subject to pre-employment and random drug testing. In addition, applicants must be able to demonstrate non-use of illegal drugs, including marijuana, for the 12 consecutive months preceding completion of the requisite Questionnaire for National Security Positions (QNSP). 

Note: Applicants will be considered ineligible for security clearance processing by the U.S. Department of Energy until non-use of illegal drugs, including marijuana, for 12 months can be demonstrated.


Testing Designated Position

This position is a Testing Designated Position (TDP). The candidate selected for this position will be subject to pre-employment and random drug testing for illegal drugs, including marijuana, consistent with the Controlled Substances Act and the PNNL Workplace Substance Abuse Program.