Now’s our time to inspire the future of healthcare together.
Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 48,000 dedicated colleagues 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 high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us.
Join our team now at Siemens Healthineers as a Quality Engineer.
This is a role well
suited to an ambitious professional, looking for the next step in their career.
As a Quality Engineer, you will be responsible for:
- As the CAPA system Administrator, you will manage the CAPA process and the CAPA system for the Tarrytown site by assigning CAPA system access, dispositioning and approving CAPA and Issue Resolution (IR) records for all Laboratory Diagnostics R&D product lines, which includes Hardware, Software, Reagents/Consumables, as well as troubleshoot and report system issues.
- You will support Quality management by ensuring that CAPAs and Issue Resolutions are issued as required, properly investigated, documented, and completed on time, by managing quality metrics and reporting KPIs to management. You will investigate any KPI failures and communicate to senior management obstacles, provide solutions and lead implementation of new opportunities for improvements to work processes, production, QA review and other areas as identified.
- You will represent the Tarrytown site during audits and inspections (both internal and external) of the CAPA process.
- You will chair R&D Corrective and Preventive Action Review Board (CARB) meetings and develop meeting outcomes to ensure continual improvement of the CAPA process.
- You will ensure compliance to regulatory requirements per CFR §820, ISO 23485, CDMR and other applicable regulations and company procedures for CAPA systems.
This position may suit you best if you are familiar
with what is below, and would like to do develop your career with
- You will chair the CAPA/IR meetings to assist with the initiation of all CAPAs and IRs for the Tarrytown site and ensure CAPA owners are prepared to present during CARB meetings, CARB activities are completed (this includes approval of CAPAs on behalf of the CARB) and CARB meeting minutes are retained.
- You will train assigned individuals on root cause analysis methodologies to ensure correct root cause identification, appropriate action plan identification and effectiveness verification are achieved.
- You will ensure effective CAPA and nonconformance data analysis and evaluate their trending.
- You will be responsible for creating and revising CAPA procedures, work instructions, templates and guidance documents, as needed.
- You will represent Tarrytown at the CAPA Network meetings and communicate best practices and continuous improvement opportunities within the CAPA process.
- You must have the ability to analyze and solve complex problems as well as the ability to communicate effectively across departments, which is crucial in this role, and demonstrate effective influencing and change management skills and demonstrate achievements in process improvements.
- You have good PC skills (MS Office software like Word, PowerPoint, Excel and Outlook)
Required skills to have for the success of this role
- Bachelor’s degree or equivalent experience required in related discipline, or equivalent combination of education and experience.
- Strong leadership skills and ability to influence cross-functional teams to drive successful CAPA outcomes.
- Position is located at the Tarrytown site and candidate must be available to be on site a few days a week and during audits.
- Willing to travel up to 20%.
At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.
Siemens Healthineers has recently announced the next steps in our continued commitment to prioritize colleague health, comply with customer/business partner requirements, and help preserve our business continuity. Going forward, please be aware that Siemens Healthineers requires full vaccination for all new hires by their start date. (Note: Accommodations may be requested for certain medical or religious reasons).
If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers.
If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about.As an equal-opportunity employer we are happy to consider applications from individuals with disabilities
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Experienced Professional
Job Type: Full-time
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