Quality Engineer

3 weeks ago

Orrville, United States Holtec International Full time

ROLES and RESPONSIBILITY:

Holtec Quality Engineer is responsible to provide a technical foundation for developing/ supporting Holtec operations as required to comply with the requirements of 10CFR50 Appendix B, NQA-1, ASME Section III, ASME Section VIII, ISO 9000 and other industry consensus. The Quality Engineer shall provide oversight and guidance to ensure compliance with suppliers, oversight, and the manufacturing facility. The Quality Engineer will coach supplier and manufacturing colleagues on proper compliance along with identifying and escalating quality issues, to ensure product quality and proper techniques. May have cross functional training and aid with manufacturing operations and the test laboratory. In this position, the Quality Engineer will be a member of the quality assurance team that assures product and process documents match the specifications based on established specifications, codes, standards and procedures along with identifying, tracking and closure of deviations from established standards, in the manufacturing of products.  The Quality Engineer reports directly to the Quality Manager.

QUALITY ENGINEER JOB REQUIREMENTS:

  • Strong interpersonal and communication skills to interact with all Holtec teams.

  • Perform defect trend analysis and root cause analysis of Holtec nonconforming material and processes.

  • Create, evaluate, trend and oversee the results of internal and external corrective action request.

  • Generate, revise and implement Holtec Work Instructions.

  • Support internal and external surveillance and/or audits of Holtec and/ or vendor operations and processes.

  • Provide technical support for work in process activities, new product evaluations, test and inspection activities as required.

  • Provide technical support to Holtec Teams.

  • Support Holtec receiving inspection requirements.

  • Provide support for Measuring and Test Equipment maintenance and calibration requirements.

  • Ability to use metrology and statistical methods to diagnose and correct improper quality control practices.

  • Perform Holtec documentation and regulatory requirements to complete/verify document packages are acceptable to the Interdivision Purchase Requisition (IPR) requirements.

  • Support Holtec requirements for new hire training and annual retraining of Holtec Team members.

  • Quality Engineer to manage and/ or train the Quality Team members in the department, responsible for the performance management and assist with the hiring of employees within the department.

QUALITY ENGINEER COMPETENCIES:

  • Nuclear Safety Conscience            

  • Technical Capacity

  • Organizational Skills

  • Problem Solving/ Analytical

  • Customer/ Client Focus

  • Time Management

  • Collaboration

  • Performance Management

  • Leadership

QUALITY ENGINEER EDUCATIONAL AND PROFESSIONAL REQUIREMENTS:

  • BS Engineering or equivalent, preferred in Mechanical or Industrial Engineering; or AS degree with one year of quality assurance related work; or a high school diploma plus three years of quality assurance related work.

  • Knowledge of applicable codes including, but not limited to, 10CFR50 Appendix B, NQA-1, ASME Section III, ASME Section VIII, AST-TC-1A, ISO 9000 and other industry consensus.

QUALITY ENGINEER PREFERRED SKILLS:

  • Lead Auditor Qualifications (NQA-1, CQA)

  • Material Testing

  • Statistical process control knowledge.

  • Six Sigma analytical techniques.

  • Knowledge of Non-Destructive Examination Methods (e.g.; VT, PT, MT, etc.)

QUALITY ENGINEER SPECIAL RESPONSIBILITIES:

  • Conduct evaluations and oversight of production personnel and processes to ensure procedures are being followed in accordance with design requirements, specifications, codes, standards and regulatory guidelines.

  • Implement process improvements with a focus on quality processes.

  • Provide input and decision making for quality on the shop floor regarding manufacturing and deviations. Provide corrective action as necessary.

  • Work closely with Manufacturing and other support functions to troubleshoot during unexpected events.

  • Complete projects as identified by management.

  • Create, review and approve Good Manufacturing Practices through surveillance reporting.

  • Track, review and maintain Manufacturing & Inspection Test Plans and associated records to ensure that the information and documentation conforms to all requirements.

  • Create, review, track and close deviations and consistently produce quality work.

  • Accurately communicate supply, operational needs and escalate issues with potential impact.

  • Provide Real Time Quality impact assessments and decisions on product and equipment issues and escalate as necessary.

  • Maintain inspection readiness, support inspections from regulatory agencies & customers.

  • Participate in Improvement projects, Corrective Action / Preventative Action Effectiveness, etc. as appropriate.

  • Assist and support the manufacturing staff in detecting and solving compliance errors in real time during manufacturing and packaging operations.

  • Help to define appropriate action plans for improvement and follow-up and communicate action closures.

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