Staff Quality Engineer: Medical Devices & Compliance Leader

Nuclein, LLC.; Austin (TX); On-site; USD 120,000 - 180,000; Full time

Job summary

Nuclein, LLC. in Austin, TX is seeking a Staff Quality Engineer to support development and maintenance of the quality management system.

Reporting to the Associate Director, Product Quality, you will oversee quality activities across production, design, and regulatory efforts and collaborate with Operations, Engineering, and Assay Development teams as well as suppliers. This role requires leading cross-functional teams, driving supplier quality, conducting audits, and advancing the QMS, with a

Qualifications

• BS in Engineering or Science (required).
• 10+ years in quality or regulatory roles in medical devices or FDA-regulated environments.
• Experience with ISO 13485 and IVDs preferred, with strong cross-functional leadership.

Responsibilities

• Ensure manufacturing and testing of medical device IVDs complies with GMPs and Nuclein procedures.
• Lead supplier audits and supplier quality programs; manage change control and deviation processes.
• Develop and improve the QMS; author procedures and work with internal/external stakeholders during inspections.
• Mentor teams on quality principles and drive cross-functional project timelines.

Skills

Quality management

Risk management

Regulatory compliance

Cross-functional leadership

Documentation control

Education

BS in Engineering or Science

Tools

QMS software

Audit software

Job description

Nuclein, LLC. in Austin, TX is seeking a Staff Quality Engineer to support development and maintenance of the quality management system.

Reporting to the Associate Director, Product Quality, you will oversee quality activities across production, design, and regulatory efforts and collaborate with Operations, Engineering, and Assay Development teams as well as suppliers. This role requires leading cross-functional teams, driving supplier quality, conducting audits, and advancing the QMS, with a