Job Summary:

The Quality Compliance Engineer II is responsible for maintaining compliance to all applicable global regulations, including materials of concern compliance, industry standards, and quality system requirements governing medical devices, combination medical device/pharmaceutical products, and software products, as applicable. This role fosters collaborative relationships across cross-functional departments to drive a culture of compliance, quality excellence, and continuous improvement throughout the organization.

The Quality Compliance Engineer II provides guidance on the interpretation, implementation, and ongoing maintenance of compliance obligations, ensuring quality system processes remain aligned with evolving regulatory expectations.

This position supports the Quality Compliance workstream for EU MDR submission projects, coordinating compliance activities across multiple functions to support successful regulatory submissions and market access objectives. In addition, the Quality Compliance Engineer II monitors emerging regulations and standards, evaluates organizational impact, and advises stakeholders on the practical application of new and revised requirements. Through proactive engagement, auditing, training, and compliance initiatives, this role helps ensure sustained regulatory readiness and supports Terumo's commitment to deliver safe, effective, and high-quality products to customers and patients worldwide.

This role offers hybrid or remote work arrangements. However, onsite attendance is required for audits, inspections, and other business-critical meetings and activities.

Job Details:

• Ensure TMC is effectively monitoring all new and revised external regulations and standards.
• Partner with Quality Compliance Process Manager to establish time-bound product plans to conduct gap assessments and remediation activities within the required timeframes.
• Provides guidance on the interpretation, implementation, and integration of global regulations and industry standards to ensure sustained compliance and inspection readiness.
• Maintains expertise in quality management standards and regulations applicable to Terumo Medical Corporation including but not limited to the current revisions of ISO 13485, ISO 14971, FDA 21 CFR Part 820, EU MDR Regulation (MDR) 2017/745, MDSAP country requirements, and GxP.
• Support less experienced staff on the skills and competency required to successfully perform their responsibilities.
• Partner with Terumo sites and subsidiaries to provide expertise on quality and compliance related issues, ensuring consistent interpretation and application of regulatory requirements, quality standards, and corporate policies.
• Support cross-functional initiatives, including New Product Development (NPD), sustaining, and acquisition projects, providing independent design control reviews and strategic compliance guidance to ensure product design and development activities align with applicable global regulations, external standards, and internal quality system requirements throughout the product lifecycle.
• Support the coordination of cross-functional stakeholder input, including Medical Affairs and PMS, to ensure Health Hazards Evaluations are comprehensive and based on accurate and complete information for the Critical Action Committee review.
• Support and/or lead quality system and product compliance initiatives driven by evolving global regulatory requirements and industry standards, ensuring timely implementation, sustained compliance, and organizational readiness.
• Provide input for the development, review, and optimization of QMS procedures, processes, and associated documentation to ensure compliance and enhance operational efficiency.
• Support organizational priorities and strategic quality objectives, including supporting third-party/regulatory audits.

Knowledge, Skills and Abilities (KSAs):

• Practical experience with FDA, ISO 13485, EU MDR, MDSAP and global quality system requirements, preferably for medical devices.
• Solid analytical and critical thinking skills.
• Demonstrated ability to effectively communicate with all levels of the organization including Leadership.
• Ability to provide clear direction to others.
• Strong interpersonal skills with the capability to influence cross functional collaboration.
• Effective proofreading and writing skills.
• Strong organizational and prioritization skills.
• Ability to navigate the grey area of a situation.
• Demonstrated decision-making skills including the ability to rapidly understand complex changes and pace work completion to the needs of the company.
• Independent decision-making on routine business tasks.
• Proven ability to multi-task and deliver timely results.
• Proficient computer knowledge (MS Office)
• Demonstrated ability to work effectively with cross- functional teams for problem-solving, product and process improvement is required.

Qualifcations:

• B.S. degree or equivalent in Scientific or Engineering discipline required.
• Master's degree in science or engineering preferred.
• Minimum of 3 to 5 years overall experience in a regulated industry, specifically medical device/diagnostic, pharmaceutical with focus on Quality System Regulations

Final compensation packages may be higher or lower than what is listed, and 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. The salary range is $72,500 - $99,660 based on experience and an 8% target bonus.