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

This position is responsible for development, establishing and maintaining quality systems programs, policies, processes, procedures, training materials, and controls enhancing the performance and quality of products and the divisional capability to demonstrate conformance to established standards and agency regulations.

Job Details/Responsibilities Designated Management representative who provides overall Quality Systems leadership including ensuring establishment and maintenance of a Quality system which is compliant with appropriate US and international regulations as well as Terumo Corporation’s Quality Policies. Provide expert level guidance and direction of the Quality Systems Body-of-Knowledge. Represent Quality Systems as required in support of cross-functional projects. This position will serve as a functional representative for organizational initiatives potentially impacting or affecting the QMS. Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.   Maintain effective Quality Metrics and define and execute activities to improve quality system compliance and effectiveness. Member of TMC Quality Leadership team helping to forge quality strategies, supporting initiatives and measure for the business and Terumo Caguas facility. Reports on the performance of the quality system to management with executive responsibility for review, in both periodic management review meetings and as needed. Aggressively identify opportunities to apply, continuously improve, and redefine quality systems and controls for all product-related processes in accordance with applicable internal, domestic, and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc. Aggressively identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility. Provide inspirational leadership to the Quality Systems staff.  Support and drive their continued career development. Be a champion of Quality, Six Sigma, Lean and disciplined problem solving throughout the organization. Identify Quality Initiatives and lead cross-functional teams to complete them. Assess resource needs to assure that the accurate level of quality support is provided when needed with the competencies needed. iaison with Corporate Global Quality organization on QMS initiatives. Host/manage third party and internal corporate audits. In coordination with the divisional training function, oversee, develop, and provide training to personnel on Quality Management System topic training. Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Sets goals which align to department plans and manages the execution of goals through coaching and mentoring. Maintains a safe and professional work environment. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. 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.  Performs other related duties and responsibilities, on occasion, as assigned.
  Job Responsibilities (continued) Working Conditions/Physical Requirements Knowledge, Skills and Abilities (KSA) Demonstrated organizational influence to include, but not limited to compliance excellence, organizational improvement, product-related risk mitigation, and/or manufacturing cost reduction. Medical Device manufacturing experience (FDA Class III preferred). Unwavering ethical resilience, high standard of personal integrity, and a non-financially encumbered moral compass.  Ability to work in a highly matrixed and geographically diverse business environment.  Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.  Ability to work effectively within a team in a fast-paced changing environment.  Multi-tasks, prioritizes and meets deadlines in timely manner.  Strong organizational, planning, and follow-up skills and ability to hold others accountable.  Ability to travel approximately 25%, including internationally.  Willingness to relocate and be open to global mobility assignments.  Ability to maintain regular and predictable attendance.  Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization in Spanish and English.
  Qualifications/ Background Experiences Bachelor’s degree in Engineering discipline, EIT, PE or CQE preferred, or equivalent industry-related experience, master’s degree preferred. Minimum of (10) ten years of experience in manufacturing, quality control, quality assurance, or regulatory compliance, preferably in the medical device or pharmaceutical industry. Must have previous supervision experience with at least (5) five years of direct management and supervision of personnel  Experience working in a broader enterprise/cross division business unit model preferred.  Demonstrated extensive experience with Domestic and International regulatory requirements and regulating bodies required. Demonstrated ability to build and continuously motivate a high-performing functional team. 
 

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.

Final compensation packages will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand. We provide competitive and comprehensive benefit options which include: annual bonus, 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.