Quality Systems & Regulatory Manager

We are seeking a highly organized and detail-oriented Quality Systems & Regulatory Manager to own and maintain AION's Quality Management System (QMS). This individual will play a critical role in ensuring compliance with FDA and ISO standards, managing quality processes, and supporting product quality as we scale.This is a hands-on role for someone who thrives in a fast-paced, high-growth environment and is comfortable owning quality systems, documentation, and investigations end-to-end.Key Responsibilities:Quality System Management (QMS)Own and maintain AION's Quality Management System in compliance with FDA and ISO standardsManage document control processes (SOPs, work instructions, change control)Track and manage CAPAs (Corrective and Preventive Actions)Ensure audit readiness for internal audits and external inspectionsProduct & Quality Issue ManagementLead investigations into product complaints, deviations, and non-conformancesConduct and document root cause analyses in collaboration with engineering, manufacturing, and clinical teamsEnsure timely resolution and proper documentation of all quality eventsIdentify trends and proactively recommend product and process improvementsRegulatory & Compliance SupportLead and support compliance with FDA regulations (21 CFR Part 820) and/or ISO 13485Assist with preparation for audits, inspections, and regulatory submissionsEnsure all quality processes meet regulatory and internal standardsQualifications:Required3–7 years of experience in quality, regulatory, or related roles within medical device, healthcare, or a regulated industryExperience working within a Quality Management System (QMS)Strong understanding of CAPA, change control, and complaint handling processesExceptional organizational skills and attention to detailAbility to operate in a highly hands-on, execution-focused rolePreferredExperience with FDA-regulated environments (21 CFR Part 820) and/or ISO 13485Experience supporting audits and inspectionsStartup or high-growth company experienceHaving led or participated in FDA filingsWhat Success Looks LikeA well-maintained, audit-ready quality systemStructured, timely resolution of product and field issuesClear documentation and traceability across all quality processesStrong quality foundation supporting rapid company growthWhy This Role MattersThis role sits at the core of AION's ability to scale safely and compliantly. As we expand nationally and globally, maintaining a strong quality system will directly impact regulatory success and product reliability.Why Join AION BiosystemsPlay a foundational role in shaping a new category within healthcareHigh-impact position within a rapidly expanding healthcare technology companyCompetitive compensationOpportunity to directly influence patient safety and outcomes in vulnerable populationsWe are an ISO 13485 certified companyLocationCommutable distance to Lowell, MA