Quality Systems Compliance Engineer II

Select how often (in days) to receive an alert: Department: Quality Systems & Compliance 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! Quality 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. Regulatory and Standards Compliance Lead the evaluation of new and revised regulations and standards to assess impact on products and QMS processes Maintain expertise in applicable global regulations and standards, including FDA 21 CFR 820, ISO 13485, ISO 14971, EU MDR/MDD, and Health Canada requirements Support implementation of regulatory changes through updates to QMS procedures, forms, and processes Health Hazard Evaluation (HHE) and Recalls Coordinate HHE activities with cross-functional stakeholders (e.g., Medical, PMS) to ensure timely completion Assist in preparation and execution of Critical Action Committee meetings Assist in the coordination of recall-related activities as directed Quality Systems Oversight and Compliance Monitoring Act as an independent reviewer to ensure compliance issues are properly evaluated, investigated, and resolved Monitor QMS performance and compliance activities across departments, identifying trends and areas of risk Cross-Functional Project Support Serve 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 regulations Provide guidance on quality system requirements and regulatory expectations Perform other duties as assigned Auditing Support Maintain audit readiness through ongoing training and knowledge of audit requirements Support external audits (e.g., FDA, Notified Bodies, customers) by preparing documentation and participating in audit activities. Qualifications/ Background Experiences B.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 preferred Familiarity 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 company Ability 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 reports Strong interpersonal skills to provide coaching, training, and direction with all levels of the organization Strong proofreading and writing skills, as well as exemplary attention to detail Strong 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 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 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. Nearest Major Market: Fort Lauderdale Nearest Secondary Market: Miami #J-18808-Ljbffr Terumo Cardiovascular Group