Sr. Quality Systems Engineer (TAS)

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 SummaryProvides technical support to the maintenance and improvement of the quality systems. Develops quality standards and controls. Develops, process and systems qualification protocols for new systems and existing manufacturing production lines. Advises company management on quality assurance requirements. Review non-conformance reports along with product risk assessment and performs root cause investigations. Job Details/ResponsibilitiesQuality engineering, system and process validation, project team leadership and participation, document generation and control, data analysis, corrective and preventive action.Prepares and implements quality standards, operating procedures and reporting systems.Conducts training to end-users of Quality Management Systems, specifically the CAPA process.Supports CAPA and auditing programs and performs assigned actions to address quality issues.Interacts with cross-functional teams to obtain system requirements and feedback to implement preventive and/or corrective actions.Manages and provides status of assigned projects to the management team. Identifies areas of risk and recommends mitigation actions.Prepares and implements proposals of improvement to the quality management system. Provides follow-up actions as necessary.Develops quality plans, validation plans, risk assessments and other validation related deliverables for the implementation of the CAPA Process. Ensures quality system compliance for areas of responsibility.Reviews, approves changes under the change management system, as required.Initiate investigations and product performance risk analysis for issues related to the quality management system. Leads CAPA Review Board meetings Job Responsibilities (continued)Working Conditions/Physical RequirementsQUALITY REQUIREMENTS Maintain awareness of the relevance and importance of activities performed and how they contribute to the achievement of quality objectivesWork within the QMS at all times, ensure accurate completion of records and highlight issues to immediate supervisor any issues affecting qualityResponsible to ensure facility, processes and documentation remain in a state of audit readiness at all timesEH&S REQUIREMENTSTake care of your own health and safety and that of others who maybe affected by your actionsWork co-operatively to highlight issues affecting Environmental Health and SafetyKnowledge, Skills and Abilities (KSA)Excellent Written and Verbal CommunicationUnderstanding of quality system regulations (ISO13485, 21CFR820)Working knowledge of Computerized System Validation requirements for Medical Devices (21CFR Part 11).Ability to interact with all levels within organizationAnalytical skills for compiling and analyzing dataSystems and customer service oriented. Knowledge of DOE, SPC, Gage R&R, and sampling plansComputer and software skills Ability to motivate others and work independentlyQualifications/ Background ExperiencesBachelor’s degree in a technical discipline, or equivalent, with a minimum of five years of experience in medical device quality assurance.Experience with class III cardiovascular medical devices Thorough understanding of quality system regulations (e.g. 21CFR820, ISO 13485)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.