Manager, Quality System Training

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 Quality Systems Training Manager is responsible for designing, developing, facilitating, and executing training requirements for Terumo Medical Corporation (TMC).  The objective of this training is to ensure compliance to cGMP, quality, regulatory and enterprise/corporate business requirements. As a minimum, this includes the FDA’s Quality System Regulation/Current Good Manufacturing Practices (21 CFR 820) and ISO-13485: 2016.The position, must develop and facilitate objective measures for determining the effectiveness of the training content and successful learning of training objectives. The Quality Systems Training Manager must work with key business Subject matter experts to develop, facilitate and maintain more specialized quality/regulatory and corporate training.  The individual in this position must be a self-starter with experience in developing new and innovative business and medical device quality systems training programs.  This includes developing and facilitating a training schedule, hierarchy, curriculum, records system, process for continuous improvement and a training strategy for multiple sites.  The overall business goal of the Quality Systems Training Manager is to support the development of a learning culture based upon effective compliance and continuous business improvement throughout TMC. 

Job Details:

1. Establish an effective, efficient and compliant quality systems training program for various levels and areas in TMC.  This includes exempt and non-exempt personnel such as management, quality/regulatory, design & technology and operations.
2. Manage and develop a team of quality systems training specialists.  Establish a high-performing team to drive the organizational goals & objectives and instill quality culture.  Drive engagement to ensure personnel have clear expectations, appropriate tools and information, an opportunity to share, grow and develop and are recognized for their contributions.
3. Work with functional heads to develop and deploy a role-based Quality System training curriculum and the operations training infrastructure for single and/or multiple TMC site compliance,
4. Develop a learning culture throughout the organization.  In conjunction with functional SMEs, develop effective, compliant, and engaging training material to meet global regulations.  Improve training processes to ensure accurate role-based training.  
5. Work with external training material providers to define, develop, implement and evaluate the required training materials.
6. Own the QS onboarding of new hires and train them or facilitate training on TMC Quality System policies and procedures.
7. Develop a network of SME’s to create, review, evaluate and deliver the required QS training content and materials necessary for effective Company compliance.
8. Work with SME’s to develop measures for determining and documenting QS training effectiveness measures.  Provide QS training program performance measures to Executive Leadership,
9. Manage and enhance the TMC electronic QS training system and assist with the development of an efficient training records maintenance process.
10. Support and represent the TMC Quality Systems training program during internal and external audits.
11. Follow all established Environmental Health & Safety and Quality System policies, programs, rules and practices, including but not limited to product and patient safety, the health and safety of all associates as well as the environment and community at large.
12. Perform other duties as assigned.

Position Requirements:

Knowledge, Skills and Abilities (KSAs)

• Quality and business process knowledge
  • Extensive experience with FDA, ISO 13485, EU MDR, MDSAP and global quality system requirements for medical devices.
  • Ability to establish and maintain a structured training development process (such as the Define, Develop, Implement, Evaluate and Improve process),
  • Working knowledge of managing multiple databases and Learning Management Systems (LMS’s) for a medical device and/or pharma environment,
• Leadership skills:
  • Demonstrated ability to communicate and interact with all levels of the organization including Executive Leadership. 
  • Strong interpersonal skills to provide coaching, training, and direction.
  • Demonstrated ability to provide clear direction and mentor personnel.  
  • Proven experience influencing across the organization to improve product or processes.    
• Individual skills required:
  • Strong proofreading and writing skills, as well as exemplary attention to detail.
  • Demonstrated organizational and prioritization skills
  • Exceptional decision-making including the ability to rapidly understand complex changes and pace work completion to the needs of the company.
  • Demonstrated initiative and ability to work independently while handling multiple tasks
  • Strong computer knowledge (MS Office), technical writing skills and proofreading ability
  • Demonstrated ability to work effectively with cross- functional teams for problem-solving, product and process improvement is required.
  • Ability to clearly communicate (both verbal and written), and successfully influence, all levels of the organization.

Background Experience

• Position requires a 4-year degree.
• 8 years minimum experience in training program management in a regulated industry, with increasing levels of responsibility.
• Certifications in instructional design and/or adult learning theory preferred. 
• Prior supervisory / management experience preferred.

Benefits and Compensation

We provide competitive and comprehensive benefit options that allow you to design your own plan based on your individual needs which include: paid vacation, paid holidays, health, dental and vision benefits, 401(k), with matching contributions, tax advantage savings accounts, legal plan, voluntary life and AD&D insurance, voluntary long-term disability, short term disability, critical illness and accident insurance, parental leave, personal leave, tuition reimbursement, travel assistance, and an employee assistance program. The pay range for this position is $100,800 - $151,200 

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.

We provide competitive and comprehensive benefit options that allow you to design your own plan based on your individual needs which include: paid vacation, paid holidays, health, dental and vision benefits, 401(k), with matching contributions, tax advantage savings accounts, legal plan, voluntary life and AD&D insurance, voluntary long-term disability, short term disability, critical illness and accident insurance, parental leave, personal leave, tuition reimbursement, travel assistance, and an employee assistance program.