Pillar Biosciences is looking to disrupt the NGS diagnostic space with our fabulous product and our ability to offer de-centralized testing vs sending samples to external labs. We can get results in 1 day and get patients on the precise medicine they need.

The QA/RA Manager leads planning, development and improvement of Pillar’s Quality Management System to support product, compliance and commercialization goals. In this role, you will:

- Serve as the QA/RA Lead in cross-functional development projects

- Develop, manage and maintain the documentation systems

- Develop quality system procedures, instructions and forms throughout process

- Own the core quality system processes

- Oversee training, develop, and deliver training for Quality Management System processes

- Generate metrics for critical-to-quality process

- Participate and drive quality process improvement initiatives and project teams

- Assist in establishing processes and procedures to enable international entry

- Review and approve internal CAPAs, Change Controls, Deviations and other quality processes

- Masters Degree in Bioengineering, Industrial Engineering or a closely-related field

- Three (3) years of quality assurance experience in BioTech Diagnostics, not including internships or co-ops

- Minimum two (2) year working in ISO 13485 certified or RFA regulated environment

- Must be a currently certified ISO 13485:2016 Lead Auditor

- Must have experience in the set-up and maintenance of an electronic quality system, BSI preferred

- Must have formal training in the requirements of IVDR.

- Must have deep experience in managing multi-national project

$150,322 - $150,322 a year

Pillar Biosciences aims to "Make precision medicine the first option for every patient" by developing and manufacturing targeted next-generation sequencing (NGS)-based assays and software for today’s high-throughput specialty NGS laboratories. We are seeking collaborative and independent problem solvers to support our mission.