PhAST
Opening for Quality Assurance (QA) Manager
All candidates should make sure to read the following job description and information carefully before applying. About PhAST.
PhAST is a venture-backed clinical stage AI healthcare technology company developing computer vision technology for rapidly diagnosing antibiotic resistance. Our in vitro diagnostic (IVD) platform provides clinical decision support for doctors, workflow improvement for hospitals, and helps accelerate the drug development process for pharmaceutical companies. Company headquarters are located in the biotech innovation hub of Boston (USA), with two international offices in Zurich (Switzerland) and Seoul (South Korea). This opening is for a position in the Boston, Massachusetts headquarters. Job Description . PhAST is seeking a Quality Assurance (QA) Manager. The successful candidate will be responsible for obtaining certifications, managing operations, and continuous improvement of PhAST’s Quality Management System (QMS) as PhAST completes the product life cycle and further develops additional in vitro diagnostic assays and platforms including hardware (instrument/consumables) and software. In this role, the QA manager will provide strong leadership to ensure all quality requirements are established effectively and maintained efficiently. The QA Manager will work closely with other teams (Product, Data, Engineering, Software, R&D) and the company’s contracting partners (Contract Manufacturers and Contract Research Organizations [CRO]) to ensure all parties operate under best quality practices. The QA Manager will support Regulatory Affairs (RA) by ensuring quality-related documentation and processes are audit-ready and aligned with regulatory expectations across international markets. This role reports directly to the senior management. This is a full-time on-site position. Responsibilities Maintain the QMS by following and implementing processes and procedures set forth by the quality manual as per ISO 13485:2016, MDSAP, and FDA 21 CFR Part 820 standards and requirements across all sites (US, Europe, Asia). Ensure that processes needed for the QMS to comply with these guidelines are established, implemented, and maintained. Lead efforts to achieve and maintain MDSAP and ISO 13485:2016 certification. Report to the senior management team on the performance of the QMS and any need for improvement. Draft, refine, review, and authorize QMS documents (e.g., Technical Files, Design History Files, FDA submissions, CE Marking documentation) in coordination with cross-functional (Product, Software, Data, and R&D) teams. Ensure compliance and qualification of contract manufacturers in coordination with the Product team. Ensure that design control is performed in accordance with applicable quality guidelines in coordination with Product and Software Teams. Ensure that validation activities and regulatory submissions meet applicable quality requirements, in coordination with the Regulatory Affairs team. Oversee all necessary training programs and records to maintain required certifications. Assist in the development of Standard Operating Procedures (SOP) and/or Work Instructions. Analyze processes and systems to create continuous process improvements through measurement, analysis, and improvement plans. Schedule and manage internal/external facility audits. Serve as Management Representative and Person Responsible for Regulatory Compliance (PRRC). Communicate the findings of internal process reviews and internal/third party/ISO/FDA audit(s) to the senior management team. Qualifications 5+ years of experience in a Quality Assurance or Quality Management role within the in vitro diagnostics (IVD) or medical device industry. Experience in conducting both internal and external quality audits. Experience integrating third-party procedures into an internal QMS. Proven knowledge of regulatory requirements including ISO 13485, MDSAP, FDA 21 CFR 820. Experience supporting regulatory submissions [e.g., FDA 510(k), CE Mark, IVDR] is strongly preferred. Bachelor’s degree in a science or engineering field or equivalent experience. Experienced and skilled communicator with the ability to work with people of diverse backgrounds in order to achieve a flexible and effective quality system. Ability to thrive in a rapid development environment. The intent of this job description is to provide a representation and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description. The position is available immediately. Title, salary, and equity compensation will be commensurate with experience. The candidate must be legally eligible to work in the United States. If interested, please email your resume and a cover letter to careers@phast.ai . PhAST is an equal opportunity employer and encourages women and people of all backgrounds to apply. Seniority level
Seniority levelMid-Senior level Employment type
Employment typeFull-time Job function
Job functionQuality Assurance Referrals increase your chances of interviewing at PhAST by 2x Get notified about new Quality Assurance Manager jobs in
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All candidates should make sure to read the following job description and information carefully before applying. About PhAST.
PhAST is a venture-backed clinical stage AI healthcare technology company developing computer vision technology for rapidly diagnosing antibiotic resistance. Our in vitro diagnostic (IVD) platform provides clinical decision support for doctors, workflow improvement for hospitals, and helps accelerate the drug development process for pharmaceutical companies. Company headquarters are located in the biotech innovation hub of Boston (USA), with two international offices in Zurich (Switzerland) and Seoul (South Korea). This opening is for a position in the Boston, Massachusetts headquarters. Job Description . PhAST is seeking a Quality Assurance (QA) Manager. The successful candidate will be responsible for obtaining certifications, managing operations, and continuous improvement of PhAST’s Quality Management System (QMS) as PhAST completes the product life cycle and further develops additional in vitro diagnostic assays and platforms including hardware (instrument/consumables) and software. In this role, the QA manager will provide strong leadership to ensure all quality requirements are established effectively and maintained efficiently. The QA Manager will work closely with other teams (Product, Data, Engineering, Software, R&D) and the company’s contracting partners (Contract Manufacturers and Contract Research Organizations [CRO]) to ensure all parties operate under best quality practices. The QA Manager will support Regulatory Affairs (RA) by ensuring quality-related documentation and processes are audit-ready and aligned with regulatory expectations across international markets. This role reports directly to the senior management. This is a full-time on-site position. Responsibilities Maintain the QMS by following and implementing processes and procedures set forth by the quality manual as per ISO 13485:2016, MDSAP, and FDA 21 CFR Part 820 standards and requirements across all sites (US, Europe, Asia). Ensure that processes needed for the QMS to comply with these guidelines are established, implemented, and maintained. Lead efforts to achieve and maintain MDSAP and ISO 13485:2016 certification. Report to the senior management team on the performance of the QMS and any need for improvement. Draft, refine, review, and authorize QMS documents (e.g., Technical Files, Design History Files, FDA submissions, CE Marking documentation) in coordination with cross-functional (Product, Software, Data, and R&D) teams. Ensure compliance and qualification of contract manufacturers in coordination with the Product team. Ensure that design control is performed in accordance with applicable quality guidelines in coordination with Product and Software Teams. Ensure that validation activities and regulatory submissions meet applicable quality requirements, in coordination with the Regulatory Affairs team. Oversee all necessary training programs and records to maintain required certifications. Assist in the development of Standard Operating Procedures (SOP) and/or Work Instructions. Analyze processes and systems to create continuous process improvements through measurement, analysis, and improvement plans. Schedule and manage internal/external facility audits. Serve as Management Representative and Person Responsible for Regulatory Compliance (PRRC). Communicate the findings of internal process reviews and internal/third party/ISO/FDA audit(s) to the senior management team. Qualifications 5+ years of experience in a Quality Assurance or Quality Management role within the in vitro diagnostics (IVD) or medical device industry. Experience in conducting both internal and external quality audits. Experience integrating third-party procedures into an internal QMS. Proven knowledge of regulatory requirements including ISO 13485, MDSAP, FDA 21 CFR 820. Experience supporting regulatory submissions [e.g., FDA 510(k), CE Mark, IVDR] is strongly preferred. Bachelor’s degree in a science or engineering field or equivalent experience. Experienced and skilled communicator with the ability to work with people of diverse backgrounds in order to achieve a flexible and effective quality system. Ability to thrive in a rapid development environment. The intent of this job description is to provide a representation and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description. The position is available immediately. Title, salary, and equity compensation will be commensurate with experience. The candidate must be legally eligible to work in the United States. If interested, please email your resume and a cover letter to careers@phast.ai . PhAST is an equal opportunity employer and encourages women and people of all backgrounds to apply. Seniority level
Seniority levelMid-Senior level Employment type
Employment typeFull-time Job function
Job functionQuality Assurance Referrals increase your chances of interviewing at PhAST by 2x Get notified about new Quality Assurance Manager jobs in
Boston, MA . Food Safety and Quality Assurance Supervisor Lexington, MA $120,000.00-$140,000.00 3 days ago Lexington, MA $120,000.00-$140,000.00 2 months ago Associate Director, Quality Assurance Vendor ManagementQuality Assurance Senior Manager, Technical Life Cycle Management (Cell and Genetic Therapies)Senior Engineer/Manager, Quality AssuranceQuality Assurance Manager - U.S. Toy Safety & Compliance North Andover, MA $85,000.00-$95,000.00 4 days ago Quality Manager, Combination Product and Medical Devices Boston, MA $110,000.00-$150,000.00 2 days ago Manager, GMP Operational Quality Packaging and Labeling (Hybrid)Quality Control Manager - Scheduler/CoordinatorQuality Manager for High Complexity CLIA LabSenior Manager, GMP Operational Quality, Cell Therapy (Second Shift)Supplier Quality Engineer III - External Operations Acquisition Marlborough, MA $79,700.00-$151,400.00 1 month ago Housekeeping Supervisor (Quality Assurance) Encore Boston Harbor We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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