Job Abstract

The Manager, Value Stream (VS) Quality Engineering (QE) is responsible for managing all aspects of Operations Quality Engineering functions within the value stream(s) of Access, Closure and Peripheral to which they are assigned.  They must also ensure overall uniformity in cross-VS QE operating norms and execution by coordinating and aligning with other VS QE management.  Additionally, they are responsible for ensuring compliance with the applicable regulations of all countries in which Terumo Medical either manufactures or distributes products including, but not limited to the U.S. Quality System Regulation, Japanese Pharmaceutical Affairs Laws, the Canadian Quality System Regulation, and the Medical Device Directive. 

• Manage a team of Quality Engineers in driving robust problem solving, NC reduction and continuous improvement efforts.  Drive value stream optimization through the application of proven methodologies such as Six Sigma, LEAN, Kaizen events etc.
• Manage all aspects of Operations QE within their VS, including:
  • Daily production support (Nonconformance investigations, product dispositioning, yield monitoring)
  • Organizational and Corporate quality initiatives
  • Continuous Improvements
  • Project support 
• Cooperatively and effectively partner with Value Stream Leaders, Operations Managers and Supervisors to develop and implement strategies which promote the Terumo Quality Culture throughout operations
• Proactively manage the workload and deployment of their team to ensure support of the business by evaluating resource supply vs. demand and ensuring an appropriate organizational structure and skillset/experience mix is created
• Establish and promote a work environment that supports compliance with the TMC Quality System and Terumo’s policies
• Own and maintain Process FMEA assessment and documentation
• Ensure appropriate process control plans (SPC, sampling, inspection methods) are created, maintained and are effective
• Manage operations-related CAPA activities in a complete and timely manner
• Ensure transfers to manufacturing are data driven and robustly executed
• Prepare for and support compliance audit activities in Operations
• Maintain Quality Performance Indicators in support of management oversight activities
• Support the preparation and conduct of compliance forums such as Quality System Management Reviews, Change Board Meetings, NC/CAPA Board meetings etc.
• Promote the professional growth and development of QE associates
• Performs other job related duties assigned
   

• Knowledge of national and international regulations applicable to medical devices including; Quality System Regulations, 21 CFR 820, 21CFR 803 and 804 (MDR regulations), Canadian Medical Device Regulations, ISO 14971, ISO 13485, and MDR etc., LEAN
• Prior experience in medical device manufacturing environment coupled with certifications from ASQ preferred 
• Ability to identify and help establish the strategic direction of the quality assurance system
• Ability to analyze and interpret all regulatory and quality guidelines as needed
• Demonstrate a strong understanding and working knowledge of the Quality Sciences (Acceptance Sampling, SPC, continual improvement, Six Sigma, LEAN, Design of Experiments, COQ, Cause & Effect analysis etc.)  
• Demonstrate a strong “business partner” approach and attitude providing creative and innovative solutions that meet quality standards
• Data analysis via Excel and other statistical software (Minitab, JMP, PowerBI)
• Must be proficient in Microsoft Excel, Word, PowerPoint, and Outlook

• Bachelor’s degree in engineering, science, or math required  
• Minimum of 10 years Quality Assurance experience
• Minimum 5 years Quality management experience
• Six Sigma/LEAN experience, expertise preferred