Sr. Staff Quality Engineer (IVD - Design

Company: Siemens Mobility Austria GmbH
Location: Newark
Posted on: February 25, 2021

Job Description:

Sr. Staff Quality Engineer (IVD - Design)

• Tarrytown, United States of America; Tarrytown, United States of America; Flanders, United States of America; Newark, United States of America
• Quality Management
• 236567 Job Description Now's our time to inspire thefuture of healthcare together. SiemensHealthineers is a leading global medical technology company with over 170 yearsof experience and--18,000 patents.--More than 48,000 dedicatedcolleagues in over 70 countries are driven to shape the future of healthcare.We stand with our customers around the world to support them in delivering highquality care to their patients.--An estimated 5 million patients across theglobe benefit every day from our innovative technologies and services--inthe areas of diagnostic and therapeutic imaging, laboratory diagnostics andmolecular medicine, as well as digital health and enterprise services. This iswhat truly matters to us. JobTitle: Sr. Staff Quality Engineer (IVD - Design) Job Location: Tarrytown,NY---Flanders, NJ - Glasgow, DE - with an option to work fromhome some of the time. -- Leads effective deployment of Quality Engineering tools for theeffective and efficient development, transfer, and maintenance of IVD Systems andrelated software throughout the productlifecycle. -- Utilize quality engineering principles and problem-solving skills(risk analysis, problem solving methodologies, statistical techniques, etc.) todevelop and optimize products/processes that are aligned with the overallQuality and Business vision. -- Provides guidance, recommendations, and implementation plans foradherence to new regulatory requirements or expectations related to DesignControls, Risk Management, Quality Engineering (e.g., Quality System RegulationCFR 21 Part 820, EU IVDD / IVDR, ISO 13485 standards, etc.) -- Ensures the comprehensive completion of risk management, DesignVerification, Process Validation, and Design Validation activities for productsand processes -- Support the development and validation of appropriate test methodsfor product and process performance -- Ensure active and thorough investigation of quality issues andeffective corrective and/or preventive action -- Effectively utilizes Lean and Six Sigma methodologies as appropriateto achieve optimal results -- As the SME, capable of providing competent Supplier Quality auditsupport with respect to the implementation of all Design Controls elements -- Participates as subject matter expert during regulatoryinspections. Qualifications/Skills/Experiencefor this role: Skills: Thisposition is responsible to provide direction in Design Control tocross-functional teams responsible for new product development, and Design Changesto commercial IVD hardware and software products. As a Subject Matter Expert(SME), the individual must be able to lead Quality Management System improvementprojects and Training efforts related to any of the elements within DesignControls. Education: Ata minimum, a BA/BS degree (in a Life Science, Engineering, or Physical Science preferred). Knowledge andExperience: ---Min 9 - 10 years relevant experience supporting the development and/orsustaining engineering associated with IVD hardware systems in a regulatedenvironment with a core appreciation of FDA regulations and specifically theimplementation and application of design controls. ---Strong leadership skills and ability to influence cross functional teams todrive work scope to compliant and successful completion. ---Self-starter, bias for action with ability to support projects through tocompletion. Good organization skills. ---Cross technology and cross discipline collaboration skills Thisis an individual contributor role. The DQ Professional provides specialized directionto professional counterparts on teams. Leadership and role model qualities is amust. Key WorkingRelationships: Primarilyintra-organizational contacts and external contacts. AtSiemens Healthineers, we value those who dedicate their energy and passion to agreater cause. Our people make us unique as an employer in the med-techindustry. What unites and motivates our global team is the inspiration of ourcommon purpose: To innovate forhealthcare, building on our remarkable legacy of pioneering ideas thattranslate into even better healthcare products and services. We recognize thattaking ownership of our work allows both us and the company to grow. We offeryou a flexible and dynamic environment and the space to move beyond yourcomfort zone to grow both personally and professionally. If you want to join us intransforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers. As an equal-opportunity employerwe are happy to consider applications from individuals with disabilities. Organization: Siemens Healthineers Experience Level: Experienced Professional Job Type: Full-time Equal Employment Opportunity Statement
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Keywords: Siemens Mobility Austria GmbH, Newark , Sr. Staff Quality Engineer (IVD - Design, Engineering , Newark, New Jersey