NuProbe USA Inc. 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 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.
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 years of experience in vitro diagnostic medical devices.
RESPONSIBILITIES:
- 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 a eQMS system
- Ensure of culture of compliant continuous improvement
EDUCATION & EXPERIENCE REQUIREMENT
- 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.
- Statisitical analysis a plus
- Experience with EQMS (preferred)
- Demonstrated excellence in technical writing
- Certified auditor a plus
BENEFITS
- Starting compensation from $110,000-$120,000 depending on experience. For outstanding candidates, the starting salary can be negotiated
- 20% target bonus depending on performances
- Company benefits (medical, dental, vision, 401k,401k matching etc.)
- Professional growth: at NuProbe we believe in people, and we foster professional growth
- Contribute to the success of a rapidly growing startup
VISA SPONSORSHIP
NuProbe is willing to sponsor H1-b work visa for the successful candidate
About NuProbe USA:
NuProbe USA is the US-based R&D subsidiary of NuProbe Global, a company that recently raised $62M YTD to develop novel non-invasive DNA. Its technology enables precise and comprehensive capturing of disease signatures with uniquely high sensitivity and multiplexing capability. NuProbe technologies can reduce the cost of NGS by 50-fold and improve the sensitivity of qPCR, Sanger, and nanopore sequencing by over 100-fold. NuProbe's technologies and products are globally recognized, and NuProbe has multiple partnerships with leading sequencing companies such as Illumina, Oxford Nanopore, and QIAGEN, and hospitals such as MD Anderson, Baylor College of Medicine, and Yale School of Medicine. As a global company, NuProbe also has a China site based in Shanghai and cGMP facility in Suzhou.
NuProbe is co-founded by Prof. Peng Yin at Harvard University, Prof. David Zhang at Rice University, and Dr. Victor Shi (former founding president of Qiagen Asia).
NuProbe USA is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need.
