What are the responsibilities and job description for the Staff Quality Systems Engineer position at TMC Compliance?

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 Staff Quality Systems Engineer is responsible for providing quality system leadership and insight into the global quality system requirements to support the TMC business as it continues to grow and change. They will collaborate with key internal business and technical stakeholders to work cross functionally to improve the overall Terumo (TMC) Quality Management System and provide sound design approaches to navigate the Quality System requirements to ensure compliance in a logical and efficient manner. The Staff Quality System Engineer will lead cross functional teams to drive improvement utilizing six sigma disciplines.

Job Details / Responsibilities

Develop, design, maintain, and continuously improve the TMC Quality system in accordance with applicable regulations for a global medical device corporation.

Help to streamline the quality system for efficiency, effectiveness, and compliance.

Drive the deployment of the quality system to all Terumo Medical sites and subsidiaries.

Integrate standard quality system tools for managing the quality system.

Utilize process improvement and problem-solving methodologies to continuously improve the quality system.

As the quality system technical lead, support TMC sites and subsidiaries on compliance and quality system related challenges.

Apply root cause investigation and / or process development tools (ex : six sigma) to determine changes required.

Provide quality system expertise to guide teams in implementing robust solutions.

Work with site personnel to identify root cause and corrective action plans to improve the quality system.

Act as the subject matter expert for TMC’s electronic quality management system (eQMS) and electronic document management system (eDMS)

Implement and maintain a complaint eQMS / eDMS for TMC & subsidiaries.

Drive implementation of new and improved workflows to support the growing business and / or revised requirements.

Work with all functional SMEs across all TMC sites & subsidiaries to ensure the system is effective and efficient.

Lead work with software vendor to ensure quality system requirements are met.

Generate metrics & dashboards to demonstrate the performance of the quality system.

Develop and provide training for eQMS / eDMS system as subject matter expert.

Support the development of a proactive and preventive quality systems culture throughout the business.

Mentor other quality professionals to support the organization in establishing a high performing team.

Assist with third party / regulatory audits (Customer, Notified Body, FDA)

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 job-related duties as assigned.

Knowledge, Skills and Abilities (KSA)

Quality and business process knowledge :

Extensive experience with FDA, ISO 13485, EU MDR, and multi-country Quality Systems requirements.

Ability to navigate implementing products and processes in an efficient and compliant manner.

Demonstrated ability to use root cause and process development tools (ex. Lean Six Sigma)

Ability to analyze data utilizing Power BI, Excel, Minitab, or other data analytical software.

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.

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.

Qualifications / Background Experiences

B.S. degree or combination of equivalent education, background, and experience in Scientific or Engineering discipline required.

Minimum 10 years' overall experience with at least 5 years of related experience in medical devices / diagnostics, pharmaceutical or other regulated industry required with a focus on quality system responsibilities.

Six Sigma certification required.

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. Rate of pay : $112,000 - $165,000 / year

Salary : $112,000 - $165,000

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