Quality Engineer

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:

• Representing and providing support for the Commercial Product Quality department when working on post market regulatory Hematology, Hemostasis and Plasma Proteins reagent and instrument related issues from the Escalation Review Councils (ERC), as well as support and drive to closure Product Quality Committee (PQC) and Field Corrective Action decisions and reporting, as required, related to reagent and hardware/software (HW/SW) Laboratory Diagnostics products.
• Evaluating safety complaint escalations and make decisions on Medical Device Reporting (MDRs), fully documenting those decisions., including providing support in all areas associated with MDR/MDVR reporting and trending.
• Providing Commercial Product Quality support for reagent and HW/SW Laboratory Diagnostics Product Health Teams.
• Representing and providing support for the Tarrytown site during audits and inspections (both internal and external) in the areas of post-market regulatory activities.
• Reviewing and approving all customer facing documentation.
• Performing at an advanced level in the field of Commercial Product Quality and apply advanced skills to resolve complex problems.
• Providing leadership to the Product Quality Committee in assessing and addressing product defects.
• Displaying a high level of critical thinking in bringing successful resolution to high-impact, complex, and/or cross-functional problems is expected. Demonstrate a significant knowledge of organization's business practices and issues faced and contributions to problem resolution of those issues. Experience in Quality Systems, Medical Device Reporting, Field Action and CAPA recommended.
• Good writing, communication and organizational skills necessary.
• Ensuring compliance to regulatory requirements such as CFR §803, CFR §806, CFR §820, ISO 13485, CDMR and other applicable regulations and company procedures.

This position may suit you best if you are familiar with what is below, and would like to do develop your career with Healthineers

• 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 PQC outcomes.
• Position is located at the Tarrytown site and candidate must be available to be on site occasionally and during audits.
• Willing to travel up to 5%.

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.

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.

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 COVID-19 vaccination for all new hires by their start date except where prohibited by state law.

(Note: Accommodations may be requested for certain medical or religious reasons)

Organization: Siemens Healthineers

Company: Siemens Healthcare Diagnostics Inc.

Experience Level: Experienced Professional

Job Type: Full-time

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