Quality Assurance Engineer - NOUS Imaging Inc.
St. Louis, MO 63131
About the Job
Quality Assurance Engineer
Who You Are
You are a dedicated professional with a passion for product quality and regulatory compliance within the medical device industry. Thriving in a fast-paced, cutting-edge environment, you excel in collaborating with dynamic teams to achieve excellence. You bring a detail-oriented approach to every task. Your continuous improvement mindset drives you to refine processes and enhance product quality. Your commitment to regulatory adherence and process optimization makes you a key asset in maintaining and advancing our company’s reputation for innovation and reliability.
What You Will Do
As a Quality Assurance Engineer, you will play a pivotal role in facilitating the product planning phases, verification and validation processes, supporting testing activities, driving process improvements, and ensuring adherence to quality and regulatory standards for both medical devices and computerized systems. These activities apply to both pre-market and post-market quality management. You will provide comprehensive quality assurance support throughout the product development lifecycle and assist in maintaining the quality management system.
Key responsibilities include:
- Ensuring compliance with the quality management system and relevant regulations and standards.
- Collaborating on the development and review of documentation across all product lifecycle phases.
- Coordinating verification and validation activities, including detailed scheduling, to ensure effective communication, collaboration, and timely completion of tasks.
- Support and/or coordinate supplier and computerized systems qualification, including verification, requirements, and supplier evaluations.
- Supporting audits and inspections by addressing inquiries and resolving findings.
- Assisting with bug testing processes to identify, address, and resolve issues.
- Supporting other issues identification, investigation, and resolution, as needed (such as complaints, non-conformances, and CAPAs).
- Leading continuous improvement initiatives and managing projects from inception to completion in collaboration with cross-functional teams.
What You Need
- 2 years of experience in a medical device quality department.
- Experience with US FDA 21 CFR 820.
- Experience with Software as a Medical Device (SaMD), including IEC 62034.
- Experience within a quality management system with regulated medical devices.
- Experience with facilitating verification and validation activities within medical devices and computerized systems.
- Proven ability to interpret technical information and collaborate effectively across multidisciplinary teams.
- Bachelor’s degree (within science, technology, or engineering discipline preferred).
- Excellent verbal and written communication skills.
- Above average attention to detail.
Who We Are
Turing Medical Technologies, Inc. is a transformational medical imaging software company developing unique solutions for magnetic resonance imaging (MRI). Our mission is to deliver cost-effective imaging enhancements, establish next generation data analytics, and create a patient-centric experience in the MRI suite.
We value the passion of our employees and want to see them reach their goals successfully alongside our company. You will work with a dedicated group of scientists and researchers, engineers, product managers, quality and regulatory professionals, and more who are driven by innovation and excellence. Employees are based all over the United States with our headquarters in St. Louis, Missouri. Turing Medical Technologies, Inc. is an Equal Opportunity Employer.
Visit our website at https://turingmedical.com/ to learn more about our products and our company. Don’t wait – take the next step and send a resume and cover letter to
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Source : NOUS Imaging Inc.
