Manager, VS Quality Engineering

7 days ago

Elkton, United States Terumo Medical Corporation Full time

Manager, VS Quality Engineering Date: Sep 26, 2024 Req ID: 3429 Location: Elkton, MD, US Company: Terumo Medical Corporation Department: Quality Engineering Operations Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products. We believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come. At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients. Join us and help shape wherever we go next Advancing healthcare with heart Job Summary 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. Job Details/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 Job Responsibilities (continued) Working Conditions/Physical Requirements Knowledge, Skills and Abilities (KSA) 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 Qualifications/ Background Experiences 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 It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.

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