Job details
Job type full-time
Full job description
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 industryTmc 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 patientsTmc 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 nationsTerumo 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 (i.e., 21 cfr part 820, iso 13485:2016, eumdr etc.) in an efficient mannerJob details: support the management and effectiveness of the quality management system, primarily the capa system by: providing guidance to capa teams participating on capa teams as needed reviewing content of capa root cause investigations, corrective actions, effectiveness criteria, and supporting data for adequacy, logicality, completeness, and compliance to regulatory and procedural requirements being responsible for approving corrective and preventive action plans, implementation of required activities and objective evidence, and effectiveness verification teaching and mentoring capa owners on root cause analysis and technical writing organizing the stewardship reviews of capa documentation managing the capa portfolio of projects to ensure these issues are being managed in a timely and compliant manner establishing and maintaining capa process metrics leading 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 review generate quality system standard operating procedures develop of quality system training materials, and deliver training where applicable contribute to the development of quality system performance measures lead third-party audit activities as required other duties as assigned
Knowledge, skills, abilities
Demonstrated knowledge in 21 crf part 820, iso 13485:2016, medical device directive / regulation
Strong computer knowledge (ms office), technical writing skills and proofreading ability
Strong 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 reports
Demonstrated ability to lead a group of participants from problem statement, root cause identification, and verification of effectiveness
Demonstrated ability to interact with all levels of managements, co-workers, and regulators
Must possess strong decision-making and prioritization skills
Must possess strong written, verbal, and interpersonal communication skills
Background, experiences
Position requires a 4-year degree in engineering or a scientific discipline or equivalent combination of education and work experience
Minimum 8 years’ experience in a quality engineering, compliance, or other related quality system role(s) in a medical device or pharmaceutical company
Experience performing root cause analysis/investigations
Experience supporting a regulated manufacturing operation
Experience with electronic quality system tools
Six sigma black/green belt certification preferred
Iso 13485 lead auditor certification preferred
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 lawAs 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.
