Staff Quality Engineer

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

Position Summary.

The Staff Quality Engineer will support the development, and maintain key elements, of the Nuclein quality management system. Reporting to the Associate Director, Product Quality, this role will provide quality oversight of activities surrounding production, design and compliance. In collaboration with Operations, Engineering, and Assay Development colleagues and Nuclein’s suppliers, the Staff Quality Engineer ensures that our products meet the highest standards of quality and are compliant with all applicable regulations. This role handles escalated issues independently and proposes practical solutions to resolve challenges and make improvements. Serves as Subject Matter Expert in at least one quality discipline, such as Risk Management, Process Validation, Design Control, etc. This role is intended to be multi-disciplinary supporting production, design and regulatory efforts as needed.

Essential Duties and Responsibilities.

• Ensures manufacturing and testing of medical device IVDs is performed in accordance with Nuclein procedures and Good Manufacturing Practices (GMPs)
• Completes documentation to the standard for external Regulatory Body review
• Reviews and approves manufacturing and testing/inspection records, and authorizes product release
• Leads 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, Nonconformances, Deviations and other quality records
• Leads cross functional teams on complex projects achieving timelines and mentors others on the principles of quality
• Quality representative for complex on-market design changes, new product development and regulatory submissions
• 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 10% travel)
• Manages supplier change requests, notifications, deviations, and corrective action requests
• Reviews/approves in complaints and related investigative activities
• Leads the development and improvement of the QMS through the creation of processes and authoring of procedures
• Hosts internal and external inspections/audits
• Manages external resources responsibly
• Performs other duties and responsibilities as assigned by management

Education, Qualifications, and/or Experience.

• B.S in Engineering or Science related field or equivalent experience required.
• 10+ years experience in a quality field required, experience in medical device ISO 13485 environment, or similar FDA regulated industry required
• Experience working with IVDs preferred (PCR technology/platform a plus)
• Expert experience in at least one quality discipline
• Experience interfacing directly with external resources (suppliers, regulatory bodies, consultants)
• Demonstrated ability to lead cross functional teams to achieve timelines
• Have excellent written and verbal communication skills, with ability to train others in quality principles and operations

Physical Requirements.

• Repetitive Motion: Mostly computer use
• Weight Lifting: < 25 lb
• Position: Mostly sitting
• Occasional use of PPE may be required in laboratory/manufacturing/warehouse areas

CANDIDATES MUST CURRENTLY LIVE IN THE AUSTIN, TX AREA - NO SPONSORSHIP IS OFFERED AT THIS TIME