Quality Engineer - Operations
Nuclein is an Austin-based, private equity funded company working to commercialize a cutting-edge, point-of-care, molecular diagnostic system that has received FDA EUA clearance.
Our vision is to enable simple, affordable, rapid, and accurate disease testing for everyone. We are a dedicated, talented, and diverse team of scientists, engineers, and experienced professionals who are driven to excel and make a significant contribution to the world. At Nuclein, we offer a fast-paced, dynamic, collegial environment, where individual contributions are highly valued.
The Quality Engineer – Operations will support the development, and maintain key elements, of the Nuclein quality management system. Reporting to the Associate Director, Quality, this role will provide quality oversight of operations activities surrounding production, product release, distribution, and supplier management. In collaboration with Operations, Engineering, and Assay Development colleagues and Nuclein’s suppliers, the Quality Engineer – Operations ensures that our products meet the highest standards of quality and are compliant with all applicable regulations. This role will also support other quality functions related to product development, complaint handling, and quality systems, as needed.
- Ensures manufacturing and testing of medical device IVDs is performed in accordance with Nuclein procedures and Good Manufacturing Practices (GMPs)
- Reviews and approves manufacturing and testing/inspection records, and authorizes product release
- Supports the generation/approval of documents related to equipment qualification, facility qualification, process validation, test method validation, and risk management (PFMEA, hazard analysis, etc.)
- Generates/reviews/approves equipment specifications, calibration/preventive maintenance reports, and provides support for Out-of-Tolerance (OOT) investigations
- Provides quality leadership on cross-functional teams in root cause analysis investigation, resolution, and product disposition activities
- Executes quality responsibilities related to receiving, servicing, and distribution operations
- Facilitates the Nuclein supplier quality management program and guides cross-functional partners through supplier selection, change control, and qualification processes
- Conducts supplier audits (up to 20% travel)
- Manages supplier change requests, notifications, deviations, and corrective action requests
- Participates in complaint handling and investigation activities
- Supports the development and improvement of the QMS through the creation of processes and authoring of procedures
- Performs other duties and responsibilities as assigned by management
- Bachelor's degree in Engineering, Science, or related field required
- 5+ years of experience in medical device ISO 13485, or similar FDA regulated industry, environments or an equivalent combination of education and experience required
- Experience working with IVDs preferred (PCR technology/platform a plus)
- Experience with quality inspection and testing, product release processes, and process validation
- Experience interfacing directly with suppliers (qualification, change control, etc.) preferred
- Ability to lead projects and participate as a quality subject matter expert in team environments
- Possess excellent written and verbal communication skills, with ability to train others in quality principles and operations