Sr. Quality Systems Engineer
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 $5+ billion in sales, 20,000+ 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.Job Summary: The Senior, Quality Systems Engineer shall drive TMC's efforts to ensure compliance with applicable global Quality System regulations (ie, 21 CFR Part 820, ISO 13485:2016, EUMDR etc.) in an efficient manner. Job Details: Support the management and effectiveness of the Quality Management System, primarily the CAPA system by:Providing guidance to CAPA TeamsParticipating on CAPA Teams as neededReviewing content of CAPA root cause investigations, corrective actions, effectiveness criteria, and supporting data for adequacy, logicality, completeness, and compliance to regulatory and procedural requirementsBeing responsible for approving corrective and preventive action plans, implementation of required activities and objective evidence, and effectiveness verificationTeaching and mentoring CAPA owners on root cause analysis and technical writing Organizing the Stewardship reviews of CAPA documentationManaging the CAPA portfolio of projects to ensure these issues are being managed in a timely and compliant manner Establishing and maintaining CAPA process metricsLeading activities related to the CAPA Board Work with Organizational Stakeholders to ensure CAPA and other quality system requirements are well understood appropriately incorporated into CAPA documentation and Management ReviewGenerate Quality System Standard Operating ProceduresDevelop of Quality System training materials, and deliver training where applicableContribute to the development of Quality System performance measuresLead third-party audit activities as requiredOther duties as assignedKnowledge, Skills, AbilitiesDemonstrated knowledge in 21 CRF Part 820, ISO 13485:2016, Medical Device Directive / RegulationStrong computer knowledge (MS Office), technical writing skills and proofreading abilityStrong ability to develop, communicate, and support the interpretation and implementation of comprehensive quality systems/regulatory requirements.Advanced skill in developing and maintaining spreadsheets, pivot tables, metrics, statistical applications, charts/graphs, and user-friendly reportsDemonstrated ability to lead a group of participants from problem statement, root cause identification, and verification of effectivenessDemonstrated ability to interact with all levels of managements, co-workers, and regulatorsMust possess strong decision-making and prioritization skillsMust possess strong written, verbal, and interpersonal communication skillsBackground, ExperiencesPosition requires a 4-year degree in engineering or a scientific discipline or equivalent combination of education and work experienceMinimum 8 years' experience in a Quality Engineering, Compliance, or other related Quality System role(s) in a medical device or pharmaceutical companyExperience performing root cause analysis/investigations Experience supporting a regulated manufacturing operationExperience with electronic quality system toolsSix Sigma Black/Green Belt Certification preferredISO 13485 Lead Auditor Certification preferredIt 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.