This candidate will revise and maintain the existing Quality Management System (QMS) to ensure that it complies with ISO9001. Additionally, he/she will oversee the development of a nuclear Quality Assurance Program in accordance with 10 CFR 50, Appendix B and ASME NQA-1. This individual will manage and control all aspects of Quality Assurance across all business units of Toshiba America Energy Systems within North America. He/she will be responsible for generation and maintenance of the department budget as well as the management of all personnel within the Quality Assurance Department including any field or shop employees (Quality Control).
• Manage the design, development and implementation of a Quality Management System to comply with ISO9001 as well as 10CFR50 regulatory requirements
• Develop and implement Quality System SOPs and processes to achieve ISO and 10CFR50 compliance
• Promote the ISO and 10CFR50 Quality management system use and adherence
• Oversee any revision or augmentation regarding the Quality program
• Ensure audits of the QMS are completed, QMS management reviews are conducted and compliance within the organization is met
• Ensure audits of internal quality processes are conducted
• Provide quality system education and certification as required on all relevant ISO and 10CFR50 related topics
• Interact with key customers in quality and reliability matters
• Support on-site audits by our customers and regulatory agencies
• Oversee the audit of potential vendors to obtain information regarding QA certification related to supply quality and vendor quality standards
• Manage and maintain approved supplier certification and listing
• Manage, track and maintain companywide corrective action programs
• Establish and manage lesson learned program/data base
• Set up a program to compile and analyze quality data to issue QA performance metrics reports
• This group will review customer provided specifications to help define quality assurance requirements and related considerations
• Suggest alternative methods and procedures for solving quality related problems and improving product/process quality
• Collaborate with other management personnel to formulate and establish company policies, operating procedures and goals
• Review technical publications, articles, and abstracts to stay abreast of technical developments effecting quality within related industries
• Manage corrective action request creation, responses and closures
• Align subordinates' skills and growth with corporate success
Skills And Experience
• 10+ years Quality experience with at least 5 years of nuclear and 5 years of ISO 9000
• Experience and strong understanding of ISO9001and nuclear regulatory requirements
• Experienced QA contributor to core team(s) for product and process realization
• Expert knowledge of Quality Management Systems within regulated environments
• Experience developing systems and processes to achieve compliance with ISO requirements
• Experience with leading change
• Highly organized and detail-oriented
• Results and goals oriented
• Excellent cross-functional team participation skills
• Proficiency with MS Office suite, Oracle
• Excellent written and verbal communication skills
• Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures or governmental regulations
• Ability to write reports, business correspondence, and procedure manuals
• Ability to understand, prepare, and communicate technical information to a wide range of audiences
• Ability to effectively present information and respond to questions from internal managers and customers
• Ability to lead and develop groups; demonstrates leadership by example
• Ability to work in a fast-paced and changing environment; flexible and quickly adaptable to changing priorities
Travel
25% to 50%
Education And Training
Bachelor Degree in a technical discipline preferred with a minimum of ten (10) years of related experience
Certifications And Licenses
• ASQ CQE and/or CQA preferred
• Certified internal auditor preferred
• Six Sigma Experience preferred
Physical Requirements
• Ability to travel
• Normal working environment is under office conditions. However, visits to field or supplier locations may require the intermittent climbing of ladders, access to scaffolds, and wearing of appropriate protective equipment (hard hat, safety shoes, protective eyewear, fall protection harness, etc.)
Working Environment
• Must be able to lead teams assigned to specific missions
• The working environment ranges from general office to project site, including the facilities of suppliers
• Routine contact with equipment, workplace hazards, and other employees (including subcontractors and suppliers) is to be expected
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