QA/QC Manager (Bilingual Japanese) at Memphis

Job Description

Responsibilities

• Work under the direct supervision of the Site Manager.
• Execute QA/QC activities including but not limited to:
  • Ensuring that the quality control is appropriately performed in accordance with the plan.
  • Identify the problem or nonconformance related to QA/QC, and facilitate the corrective action as appropriate.
  • Have an operational responsibility for nonconformance control on site.
  • Control the Quality Management System.
  • Control the plan and the execution of inspection and testing of the site installation work as well as the control of measuring instruments.
  • Conduct QA Patrol of Site Organization Areas.
  • Organize the internal audit in HAL.
  • Have the overall responsibility for the site organization as the auditee in case where the Internal Audit is performed.
  • Implement QA/QC Training to Site Organization
  • Hold the periodic QA meeting, and identify the quality issue from the Supervisor and installation subcontractor.
  • Check the records, which prepared by each group regularly.
  • Ensure that processes for the QMS are established, implemented and maintained.
  • Report to the Project Manager on the implementation and on any needs for improvement of the QMS.
  • Ensure awareness of specified requirements, Customer requirements, and manufacturer requirements throughout.
  • Act as a liaison with external parties for the QMS operation.
  • Coordinating cross-functional meetings of personnel related to the QA/QC activities.
  • Report on the QA/QC activity status and develop QA/QC-related documentation.
  • Report on the QC status to the QA division (Proton Beam Therapy System QA Center) as appropriate.
  • Participate in project performance review meetings and discussions.
  • Attending project coordination and owner /architect//contractor engineer meetings, and reports.
  • Monitor the schedule of the QA/QC operation.
• Support the Site Manager in the following program areas: customer contract compliance, subcontractor contract administration, installation schedule, technical compliance, document control and program communications.
• Assist in the evaluation and solution of potential field problems, referring them to Site Manager and facilitate sessions to effectively resolve issues if any.
• Assist with the research and preparation of field change requests to resolve quality issues.
• Support initiatives for continuous improvement and cost savings.
• Effectively communicate with various senior management personnel.
• Understand and perform document control functions in accordance with on-site policy and procedures.
• Perform additional assignments and responsibilities as assumed or requested by supervision.
• Plan, coordinate, and direct quality control program designed to ensure continuous production of products consistent with established standards: Develop and analyze statistical data and product specifications to determine present standards and establish proposed quality and reliability expectancy of finished product.
• Formulates and maintains quality control objectives and coordinates objectives with production procedures in cooperation to maximize product reliability and minimize costs.
• Direct, workers engaged in inspection and testing activities to ensure continuous control over materials, facilities, and products.
• Plan, promotes, and organizes training activities related to product quality and reliability.
• May investigate and adjust customer complaints regarding quality.
• Maintaining records and reports.
• Coordinating with project management teams.

 

 

Job Requirements

Requirements

• Bachelor’s degree in Engineering or a related discipline (Electrical, Mechanical, Field Measurement, Project Management, etc.) or equivalent work experiences preferred.
• A minimum of 3 years of experience as an Onsite QA/QC Manager is required. Experience should include:
  • Support of troubleshooting construction/installation problems 
  • Interpretation of technical drawings, sketches and diagrams
  • Medical facility or industrial plant service experience is preferred
• Must possess knowledge and skills required to support for the contract, as well as the ability to conceptualize requirements, anticipate tasks and recognize implied and specified tasks to ensure mission compliance.
• Strong problem-solving and communication skills.
• Flexibility to work shift work and modified hours, flexibility for on-call, local availability.
• Ability to perform required physical tasks (ladder climbing, inspection bending and stretching, moderate lifting, tool dexterity, etc.).
• Must have basic knowledge of MS Project, MS word and, Excel.
• Must demonstrate ability to work well with various personnel demonstrating a good attitude and ability to work successfully as a member of the team.
• Self-starter with excellent communication skills, organized, capable of managing multiple assignments and demonstrated ability to communicate ideas comprehensively and effectively through written and oral presentations.
• Must be able to multi-task efficiently, work in a fast paced environment with multiple parties/disciplines, and have a strong attention for detail.
• Must be fluent in speaking, reading, writing, and understanding English and Japanese.
• Thorough knowledge of calibration, metrology, and other technical equipment.
• Comprehensive knowledge of Pharmaceutical Affairs Act and ISO13485 in the area of medical devices is preferred.
• Comprehensive knowledge of FDA and related U.S. regulations, policies and guidelines in the area of medical devices is preferred.

*Must pass pre employment drug screen
*A background package must be completed on each candidate prior to hire
*Must have verifiable work history
*Must have reliable transportation

 

 

*This employer participates in E-verify

 

Country: USA, State: Tennessee, City: Memphis, Company: CLP Resources Inc. - Skilled Trade Jobs.