Quality Systems & Regulatory Manager

Quality Systems & Regulatory Manager at AION Biosystems Quality Systems & Regulatory Manager at AION Biosystems in Dracut, Massachusetts Posted in 5 days ago.

Type:

full-time

Job Description:

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 standards Manage document control processes (SOPs, work instructions, change control) Track and manage CAPAs (Corrective and Preventive Actions) Ensure audit readiness for internal audits and external inspections Product & Quality Issue Management Lead investigations into product complaints, deviations, and non-conformances Conduct and document root cause analyses in collaboration with engineering, manufacturing, and clinical teams Ensure timely resolution and proper documentation of all quality events Identify trends and proactively recommend product and process improvements Regulatory & Compliance Support Lead and support compliance with FDA regulations (21 CFR Part 820) and/or

ISO 13485

Assist with preparation for audits, inspections, and regulatory submissions Ensure all quality processes meet regulatory and internal standards

Qualifications:

Required 3-7 years of experience in quality, regulatory, or related roles within medical device, healthcare, or a regulated industry Experience working within a Quality Management System (QMS) Strong understanding of CAPA, change control, and complaint handling processes Exceptional organizational skills and attention to detail Ability to operate in a highly hands-on, execution-focused role Preferred Experience with FDA-regulated environments (21 CFR Part 820) and/or

ISO 13485

Experience supporting audits and inspections Startup or high-growth company experience Having led or participated in FDA filings What Success Looks Like A well-maintained, audit-ready quality system Structured, timely resolution of product and field issues Clear documentation and traceability across all quality processes Strong quality foundation supporting rapid company growth Why This Role Matters This 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 Biosystems Play a foundational role in shaping a new category within healthcare High-impact position within a rapidly expanding healthcare technology company Competitive compensation Opportunity to directly influence patient safety and outcomes in vulnerable populations We are an

ISO 13485

certified company Location Commutable distance to Lowell, MA