NuProbe USA Inc. is looking for a Quality Manager to lead the Quality program to establish and maintain compliance to ISO:9001, ISO:13485 and FDA 21 CFR Part 820 Quality System Regulations.
NuProbe USA has a unique portfolio of assays including research use and in vitro diagnostic applications that include PCR, qPCR, Sanger, and NGS products. NuProbe is seeking highly motivated and competent individuals with the capacity to drive continuous improvement efforts. The ideal candidate has at least five (5) years of experience in vitro diagnostic medical devices.
PRIMARY PURPOSE OF POSITION
NuProbe USA is a rapidly growing company and the successful candidate will work with cross function groups to ensure compliance for NuProbe’s proprietary technology. This position reports to the VP of Regulatory and Quality.
- Develop, implement, and manage Quality Management System processes incorporating new and updated standards, regulations, and guidelines to ensure compliance
- Provide Quality oversight and mentoring to all departments
- Provide QMS training
- Ensure compliance for quality system documents
- Assist in third party audits and inspections
- Initiate, implement, direct quality issue resolution for complaints, nonconformances, etc. and conduct root cause and CAPA investigations as required
- Provide oversight and audits of subcontractors and suppliers to determine compliance with appropriate standards and regulations
- Conduct and manage internal audits
- Serve as the Quality Representative on cross-functional teams
- Create and maintain an eQMS system
- Ensure a culture of compliant continuous improvement
EDUCATION & EXPERIENCE REQUIREMENTS:
- PhD, MSc, B.A. or B.S. degree, bio/pharma industry experience preferred
- 5+ years of QA experience
- Experience and knowledge of GxPs
- Experience in ISO9001, ISO13845 and CFR 820 QSR
- Experience with using Root Cause Analysis (RCA) tools and methodologies
- Experience with using Quality Risk Management principles
- Statistical analysis a plus
- Experience with EQMS (preferred)
- Demonstrated excellence in technical writing
- Certified auditor a plus
- Starting compensation from $110,000 - $120,000 depending on experience. For outstanding candidates, the starting salary can be negotiated
- 20% target bonus depending on performance
- Company benefits (medical, dental, 401k, etc.)
- Professional growth: at NuProbe we believe in people, and we foster professional growth
- Contribute to the success of a rapidly growing startup
- Occasional standing, walking, and sitting; must regularly lift and/or move up to 20 pounds.
NuProbe is willing to sponsor H1-b work visa for the successful candidate
About NuProbe USA:
NuProbe is a genomics company with proprietary technology to reduce the cost and improve the sensitivity of NGS by 100-fold. NuProbe's technologies have been featured in journals such as Nature Biomedical Engineering, Nature Chemistry, Cancer Discovery, and Nature Communications, in collaboration with collaborators from MD Anderson, Baylor College of Medicine, Thermo Fisher, Oxford Nanopore, and Microsoft Research. To date, NuProbe has raised more than $60M, and its US office based in Houston, TX has over 50 full-time employees. NuProbe's senior management team includes industry veterans from Adaptive Biotechnologies, Thermo Fisher, Nanostring, Roche, and Allergan.