QA/RA Manager

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 $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. 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.  Apply for this job