Terumo Medical Corporation Quality Engineer II in Campbell, California
Quality Engineer II
Job Summary: The Quality Engineer (QE) will be responsible for developing, facilitating, maintaining and improving Quality System of Silicon Valley Labs (SVL), a division of Terumo Medical Corporation, in accordance with applicable quality systems and regulatory requirements. At a minimum, this includes compliance to the FDA’s Quality System Regulation/Current Good Manufacturing Practices (21 CFR Part 820), ISO 13485, and Medical Device Directive. The successful candidate will drive Quality System improvements companywide ensuring policies, procedures, and standards are current, compliant and addressing the needs of the business. The successful candidate will also be responsible for developing and sustaining internal processes key to optimal performance of the Quality Management. Other quality system functions will be included upon growth of the business. The QE will collect and manage data and information, including audit findings, customer complaints, and customer surveys, necessary to assess the performance of the QMS. This scope includes analyzing key metrics for trends indicating the effectiveness of the QMS, making recommendations regarding system improvements and facilitating the training required to implement the improvements. The QE will monitor, analyze, and report Quality Management System metrics to Senior Management, Management Representative, and key clients. As a minimum, this role will support Document Control, Equipment Management, Supplier Management, Management Reviews, Quality Systems Scorecards and Quality Performance Index (QPI). The successful candidate will support and participate in cross-functional projects when assigned, facilitate technical innovations to support business goals and assist with other Quality System activities as requested by management. In summary, the QE must support the development of a quality/business culture throughout SVL that is based upon effective compliance and continuous business improvement.
Job Details: 1. Set up and maintain complete Quality Systems documentation (SOP's and other related documentation) in accordance with, Quality Systems and other regulatory requirements and acceptance. These systems may be paper and/or electronic. 2. Once systems for documentation are complete, maintains filling of all master documents. In addition, will routinely audit all documentation systems to assure traceability and retrievability. 3. Responsible for facilitating efforts to plan, implement and maintain a plan of action to revise the existing Quality System in accordance with compliance requirements and the strategic needs of the business. 4. Perform as equipment coordinator for the Equipment Management program. Review and approve equipment documentation in accordance with Quality system requirements. Coordinate the implementation of Calibration and Maintenance program for company tooling and equipment. May be required to keep log and records of such activities in accordance with Quality System requirements. May work with other Engineering staff to onboard new equipment, coordinate calibration activities, and ensure accurate records for the calibration and preventative maintenance. 5. Assist in the coordination and communication of suppliers for supplier qualification file maintenance as requested. 6. Perform receiving activities including receiving inspection, manage inventory, transfer material to production and R&D. Prepare any shipping documentation and packaging for components, subassemblies, and product. 7. Responsible for coordinating the required training for all users on the major quality systems revisions and improvements. 8. Facilitate the incorporation of quality systems/regulatory requirements in accordance with FDA QSR (21 CFR Part 820), ISO13485: 2016, European MDD / MDR, and all other applicable regulations. 9. Facilitate the incorporation of a process risk management procedure that defines the incorporation of a risk based strategy for process changes, development, validation and continuous improvement. 10. Analyze, develop and maintain key metrics for trends indicating the effectiveness and suitability of the QMS and identify areas for improvement. 11. Make recommendations regarding system improvements and training required to implement the improvements. 12. Provide active support for internal, third party and customer audits. This requirement includes the post audit requirements for reviewing, dispositioning, mitigating and incorporating any observations, nonconformances, opportunities for improvement and potential gaps/preventive actions. 13. Provide practical, useful and effective quality systems reports for senior management, management reviews, business strategic initiatives and specific requests. 14. Complete other responsibilities as assigned.
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Knowledge, Skills and Abilities (KSAs)
Knowledge of national and international regulations applicable to medical devices including; 21 CFR 820 (Quality System Regulations), 21CFR 803 and 804 (MDR regulations), ISO 13485, and MDD 93/42/EE.
Proficiency in Microsoft Office applications as well as other Document Control software applications.
Ability to interact effectively (both verbal and written) with associates across all departments within an organization at all levels.
Must have strong proofreading skills and organizational skills, as well as exemplary attention to detail
Must have demonstrated initiative and ability to work independently and under supervision of senior-level employees while handling multiple tasks.
A 4-year degree in engineering, scientific discipline, or similar.
Minimum of 2 years of experience supporting a medical device/pharmaceutical/or related environment improving quality systems for manufacturing of Class II or III medical devices.
Must possess strong written, verbal and interpersonal communication skills
Experience in writing SOPs and/or other documents.
Experience in document control, equipment management, and/or supplier management. (Preferred)
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 Staffing@Terumomedical.com.
Terumo Medical Corporation
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