Quality Engineer

About Nuclein:

Nuclein is an Austin-based, private equity funded, medical device company that offers an innovative, FDA EUA authorized, rapid PCR, point-of-care system. The Nuclein® DASH™ Rapid PCR System is easy-to-use, affordable, and provides PCR results in only 15 minutes.

Nuclein is an Austin-based, private equity funded, medical device company that offers an innovative, FDA EUA authorized, rapid PCR, point-of-care system. The Nuclein DASH™ Rapid PCR System is easy-to-use, affordable, and provides PCR results in only 15 minutes.

Our visionis to enable simple, affordable, rapid and accurate 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, exciting, collaborative environment where individual contributions are highly valued as we work to expand the use of our transformative testing technology in the market.

Please visit Nuclein.com for more information about our company's history, technology, and vision.

Position Summary:

The Quality Engineer will support the development, and maintenance, of Nuclein’s quality management system, in addition to supporting ongoing quality operations and supplier quality initiatives. This role will collaborate with the Operations, Engineering, and Assay Development teams, and Nuclein’s suppliers and vendor partners, to ensure that the company’s products meet the highest standards of quality and are compliant with all applicable regulations.

Responsibilities:

• Ensures compliance to 21 CFR Part 820, ISO 13485, and other applicable regulations by providing support through interpretation of regulations, authoring procedures,
• Supports the development and maintenance of the document control, change control, training, inventory management, and calibration/maintenance systems and performs administrative duties as required
• 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 design control, process, and system verification and validation
• Provides quality leadership on cross-functional teams in root cause analysis investigation, resolution, and product disposition activities; approves non-conformance reports/CAPA records
• Supports calibration and maintenance activities
• Support process validations
• Collect, analyze, and report Quality System data to drive improvements to the QMS
• Facilitates the Nuclein supplier quality management program and guides cross-functional partners through supplier selection, audit, change control, and qualification processes
• Executes quality responsibilities in complaint handling and reporting to regulatory authorities
• Performs internal audits and supports external 3rd party inspections/audits
• Perform other duties and responsibilities as assigned by management

Qualifications:

• Bachelor’s degree in Engineering, Science, or a related field
• At least 3 years of experience in a quality, operations, engineering, or related role in an CFR 820 and ISO 13485-2016 cGMP role
• Have excellent written and verbal communication skills – able to train others in quality principles and operations
• CQE desired