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.
Job Title: Sr. Staff Quality Engineer (IVD – Design)
Job Location: Tarrytown,NY- Flanders, NJ - Glasgow, DE - with an option to work from home some of the time.
· Leads effective deployment of Quality Engineering tools for the effective and efficient development, transfer, and maintenance of IVD Systems and related software throughout the product lifecycle.
· Utilize quality engineering principles and problem-solving skills (risk analysis, problem solving methodologies, statistical techniques, etc.) to develop and optimize products/processes that are aligned with the overall Quality and Business vision.
· Provides guidance, recommendations, and implementation plans for adherence to new regulatory requirements or expectations related to Design Controls, Risk Management, Quality Engineering (e.g., Quality System Regulation CFR 21 Part 820, EU IVDD / IVDR, ISO 13485 standards, etc.)
· Ensures the comprehensive completion of risk management, Design Verification, Process Validation, and Design Validation activities for products and processes
· Support the development and validation of appropriate test methods for product and process performance
· Ensure active and thorough investigation of quality issues and effective corrective and/or preventive action
· Effectively utilizes Lean and Six Sigma methodologies as appropriate to achieve optimal results
· As the SME, capable of providing competent Supplier Quality audit support with respect to the implementation of all Design Controls elements
· Participates as subject matter expert during regulatory inspections.
Qualifications/Skills/Experience for this role:
This position is responsible to provide direction in Design Control to cross-functional teams responsible for new product development, and Design Changes to commercial IVD hardware and software products. As a Subject Matter Expert (SME), the individual must be able to lead Quality Management System improvement projects and Training efforts related to any of the elements within Design Controls.
At a minimum, a BA/BS degree (in a Life Science, Engineering, or Physical Science preferred).
Knowledge and Experience:
• Min 9 – 10 years relevant experience supporting the development and/or sustaining engineering associated with IVD hardware systems in a regulated environment with a core appreciation of FDA regulations and specifically the implementation and application of design controls.
• Strong leadership skills and ability to influence cross functional teams to drive work scope to compliant and successful completion.
• Self-starter, bias for action with ability to support projects through to completion. Good organization skills.
• Cross technology and cross discipline collaboration skills
Direction of Others:
This is an individual contributor role. The DQ Professional provides specialized direction to professional counterparts on teams. Leadership and role model qualities is a must.
Key Working Relationships:
Primarily intra-organizational contacts and external contacts.
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.
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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