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Campbell, CA Full Time Posted by: Terumo Medical Corporation Posted: Thursday, 14 January 2021
 
 
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: Principal Quality Engineer is a hands-on key position with responsibility for compliance to the US Quality Systems Regulations, ISO 13485 and the Medical Device Directive. ÊPrincipal Quality Engineer will assure and maintain compliance for quality systems as defined in the companyÕs quality manual: ÊSupplier controls, Equipment controls, Nonconformance control, CAPA, Complaint handling and adverse event reporting, Field actions, Document control, Training, Production and Acceptance activities, etc. Ê Principal Quality Engineer will collect, analyze and present quality metrics of overall fitness and effectiveness of Quality Systems to management as well as monthly overall key metrics development, analysis and report out to senior staff. ÊPrincipal Quality Engineer will provide periodic analysis of quality data and reports to management proactively on future improvement opportunities as well as status of initiatives in process while monitoring results of completed projects.Ê Principal Quality Engineer will maintain Quality data integrity as well as on-going Quality record retention. Will maintain existing Quality processes and lead new improvements in Quality related functions or improvements. Will maintain in-depth knowledge of best industry practices related to Quality and provides technical leadership to staff, peers, management and other functional areas based on in depth research and overall academic knowledge or industry experience. Job Details Quality Systems Support the Quality System and Quality Policy. Implement quality system procedures and requirements, document training and Be aware of the regulatory requirements and ensure compliance.Ê Create new processes and/or enhance documentations to assure compliance at all stages of the company growth and development. Assure documentation is established, clearly defined or described, and followed by personnel and provide training.Ê Documentations may include flowcharts, templates, checklists, training aids, forms, etc.Ê Assure audit readiness at all times. Support compliance audits, propose corrections, corrective actions, preventive actions, and perform effectiveness verifications.Ê Report audit results to management. Ê Assure training remains up to date. Coordinate and/or provide training to company personnel for quality system procedures, annual Quality System Regulation/ISO 13485/MDD and other training as required.Ê Provide support of all Internal Audits and supports all External Auditors from agencies, suppliers, or Corporate Manage CAPA activities for effective results. Perform or participate in complaint handling/adverse event reporting activities that may include returned product investigations.Ê Report findings within the complaint handling processes and in accordance with procedure requirements.Ê Maintain current knowledge of applicable standards and regulations.Ê Ê New Product Introduction/Design Control Quality Assure design control activities are performed in accordance with released procedures and in compliance with regulations and standards. Participate in product technical, dFMEA, pFMEA, and design reviews. Participate in risk management activities that involve the development and maintenance of the risk management file and assure sustained compliance with procedures, regulations and standards.Ê Proactively, update risk management file documentation as needed. Perform design history file reviews as required by procedures. Author, perform technical review and approval of design verification test protocols/reports. Assist RD in material selection (specification generation, supplier selection, test labs activities for biocompatibility tests) and sterilization method facilitating and reviewing protocols and reports. Complete quality and regulatory impact assessments when product changes are proposed (sterilization, biocompatibility, design specifications, supplier or material changes, etc.) Perform data collection, statistical analysis and provide reports to management as required and initiate investigation activities as needed. Ê Quality Operations Support quality operations activities as needed that may include inspection, testing, production history record review.Ê Supplier management implementation and maintenance activities.Ê Assure suppliers are qualified based upon the risk level assigned and that re-evaluations are performed according to procedure requirements.Ê Assure supplier monitoring activities are addressed in a timely manner (supplier caused NCMRs, supplier audit responses, etc.). Equipment management implementation and monitoring activities, ie calibration, preventive maintenance, inspection, installation/operation/performance qualifications.Ê Assure on-going monitoring is performed according to procedure requirements and that any issues or nonconformances are addressed in a timely manner.Ê Engineering change control review and approval of production documentation and assure supporting justification/rationale is documented and provided. Generate NCMRs and/or CAPAs when nonconformances are identified and addressed in a timely manner according to procedure requirements.Ê Review of sterilization load documentation and assure compliance with validation requirements, ie in charge of lot release testing.Ê Ê Supervision: May be required to lead or train Engineers, Assemblers and Technicians in the project group. Ê Safety: Perform job functions in a safe and effective manner. Ensure that employees under position supervision are adhering to the safety procedures of the company. Ê 0ther Duties: ÊAs assigned. Ê Ê Qualifications + Position Requirements: + (Knowledge, Skills and Abilities)Ê + Strong analytical and problem solving skills; ability to solve complex problems and implement solutions or processes. Strong troubleshooting skills for solving process and design issues during product development. + Demonstrated ability to distill complex technical information and explain to a non-technical audience.Ê + Demonstrated strong technical writing, validation, SOP and presentation skills.Ê (written communication) + Effective communication across all levels of the organization.Ê Strong verbal and written communication skills, ability to present to a broad audience (company personnel, suppliers, customers). + Works well under pressure; organized and self-motivated; independent contributor and strategic thinker, planner + Team leadership and development skills and ability to work effectively with all functions; internal and external + Lead training of quality personnel to applicable standards + Proficiency using Microsoft Office and Windows¨ applications; Word, Excel, PowerPoint, etc. + Excellent Project Management, Organization and Reporting skills; project basis + Effective Root Cause Analysis through process skills; ability to make things happen + Ability to independently author documents; creativity, focus, experience and clarity + Proven ability to implement and utilize FMEA methodologies; Process Mapping, Flow Diagrams, DOE, etc. + Execution Minded; do what needs to be done and deliver on promises and critical communication + Experience developing, implementing and maintaining ISO Certification requirements + Process validation experience; experience in validating product manufacturing processes to FDA compliance + Ability to Maintain Quality Systems; collaborate in conceptualization and support implementation + Responsiveness to assigned projects; respectful behavior traits, ownership and loyalty + Ability to work extended hours as necessary to achieve goals and accomplish tasks; flexible work schedule + Experience with catheter manufacturing and assembly methods preferred. + Background Qualification Experience: + + Ê + Bachelor degree in Sciences, Engineering or related discipline required or equivalent combination of education, training and experience.Ê Experience in themedical device industry a strong plus. + Extensive experience and knowledge of FDAÕs Quality System Regulations, ISO 13485 and Medical Device Directive.Ê Experience with other regulations is desired (Canada, Japan, etc.) + 8+ years previous experience in medical device industry in design, manufacturing or quality engineering positions.Ê Knowledge of sterilization and biocompatibility is desired. + Experience in a start-up environment is preferred. + Familiar with Design Control procedures and requirements + Excellent communications skills (both written and verbal) required. + Ability to work independently or in team setting required. + May be required to travel. 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. Job Category: Manufacturing Affirmative Action/Equal Employment Opportunity Statement It is the Company'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. In compliance with the Americans with Disabilities Act (ADA), if you have a disability and would like to request an accommodation with regard to the application and selection processes (for example, the online application process or interviews) or have any questions about our website accessibility, please call 732-302-4902 or e-mail us at (see below)

Campbell, CA, United States of America
Engineering
Terumo Medical Corporation
Click apply
JS787_1412687801
1/14/2021 11:10:08 AM


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