Quality Compliance Engineer II

At Terumo Aortic, our mission is to transform the treatment of aortic disease worldwide. With our comprehensive portfolio of surgical, endovascular and hybrid technologies, we enable physicians to find the right fit for each patient anatomy.The company has over 1,250 associates around the world with manufacturing facilities in Glasgow, Scotland and Sunrise, Florida.Terumo Aortic is focused on the continuing development of new and innovative products driving the growth of the business globally. Associates are part of a stimulating and exciting environment in which they can develop their skills and achieve career goals. Working for the company, each associate’s role contributes greatly to helping to save or improve the lives of patients in over 100 countries worldwide.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 heartJob SummaryQuality Systems Compliance Engineer II supports and enhances the Quality Management System (QMS) to ensure compliance with applicable regulatory requirements and industry standards. This role serves as a cross-functional compliance subject matter expert, driving quality system improvements, regulatory alignment, and effective execution of quality processes.Job Details/ResponsibilitiesRegulatory and Standards ComplianceLead the evaluation of new and revised regulations and standards to assess impact on products and QMS processesMaintain expertise in applicable global regulations and standards, including FDA 21 CFR 820, ISO 13485, ISO 14971, EU MDR/MDD, and Health Canada requirementsSupport implementation of regulatory changes through updates to QMS procedures, forms, and processesHealth Hazard Evaluation (HHE) and RecallsCoordinate HHE activities with cross-functional stakeholders (e.g., Medical, PMS) to ensure timely completionAssist in preparation and execution of Critical Action Committee meetingsAssist in the coordination of recall-related activities as directedQuality Systems Oversight and Compliance MonitoringAct as an independent reviewer to ensure compliance issues are properly evaluated, investigated, and resolvedMonitor QMS performance and compliance activities across departments, identifying trends and areas of riskCross-Functional Project SupportServe as a Quality and compliance SME on cross-functional projects (e.g., New Product Development, sustaining engineering, acquisitions)Perform independent reviews of design control activities to ensure compliance with internal procedures and external regulationsProvide guidance on quality system requirements and regulatory expectationsPerform other duties as assignedAuditing SupportMaintain audit readiness through ongoing training and knowledge of audit requirementsSupport external audits (e.g., FDA, Notified Bodies, customers) by preparing documentation and participating in audit activities.Qualifications/ Background ExperiencesB.S. degree or equivalent in Engineering or Scientific discipline required or relevant experience with equivalent combination of education and experience.3-5 years' overall experience required with at least 3 years of related experience in medical devices/diagnostics, pharmaceutical or other regulated industry required with a focus on product or production, or quality-related responsibilities preferredFamiliarity with FDA, ISO 13485, EU MDR, and multi-country Quality Systems requirements.Ability to identify and recognize how the standards & regulations potentially affect the wider business of the companyAbility to use process development tools (ex. Lean Six Sigma)Ability to apply a practical level of statistics. Ability to develop and maintain spreadsheets, pivot tables, metrics, statistical applications, charts/graphs, and user-friendly reportsStrong interpersonal skills to provide coaching, training, and direction with all levels of the organizationStrong proofreading and writing skills, as well as exemplary attention to detailStrong 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 tasksIt 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 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.