26 applicants
Terumo Medical Corporation · 2 days ago
Quality Engineering Manager
Elkton, MD
Full-time
Onsite
Senior Level
7+ years exp
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Hiring Manager
Julia Campbell
Insider Connection @Terumo Medical Corporation
Responsibilities
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
Qualification
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Required
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
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 7 years Quality Assurance experience
Minimum 5 years Quality management experience
Preferred
Six Sigma/LEAN experience, expertise preferred
Experience in medical device manufacturing environment coupled with certifications from ASQ preferred
Company
Terumo Medical Corporation
Terumo Medical Corporation is one of the world’s leading manufacturers of medical devices and supplies.
1,001-5,000 employees
H1B Sponsorship
Terumo Medical Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (2)
2022 (2)
2021 (3)
2020 (3)
Funding
Current Stage
Late StageLeadership Team
Shahnawaz Khan
CTO & Head of IT
Michael J M.
Sr. VP, Medcal Affairs, Chief Medical Officer
Recent News
2023-12-29
2023-12-29
Company data provided by crunchbase
