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
Requirements:
- 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
This is an on-site role, Monday - Friday from 8:30am - 5:00pm in Natick MA
Relocation support is not available for this role
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.
Pillar Biosciences is an Equal Opportunity and Affirmative Action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; religion; age; nationality; marital status; sexual orientation; disability or any other characteristic protected by law.
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