Quality & Compliance Specialist

Quality & Compliance Specialist

A growing medical device company based in the Los Angeles area is seeking a Quality & Compliance Specialist to join their QA team. The company develops next-generation biometric sensor devices for hospital use and cloud-based clinical software solutions. The Quality & Compliance Specialist will be responsible for the day-to-day administration and maintenance of the company's Quality Management System. This role manages the document control lifecycle in Greenlight Guru, supports internal and external audits, tracks complaints and postmarket issues, and drafts new procedures as the QMS matures. This individual will serve as the operational link between Regulatory, Quality, Product, and Operations — ensuring procedural compliance, documentation integrity, and audit readiness across all functions. This role will require working onsite 3-4 days/week at the LA office.

Core Responsibilities:

• Administer and maintain the Greenlight Guru (GLG) QMS platform: manage change orders, document workflows, approval routing, and user access.
• Own the document control lifecycle — draft, route, track, and archive SOPs, Work Instructions, templates, and forms in GLG. Ensure version control is maintained and all documents are current.
• Draft, revise, and format QMS procedures, Work Instructions, and supporting templates as the system evolves. Work with subject matter experts to translate process requirements into clear, audit-ready documentation.
• Maintain the controlled document register and ensure all expired or superseded documents are properly archived.
• Support preparation for and participation in external audits — FDA inspections, Notified Body audits, and ISO 13485 surveillance audits. Coordinate document readiness, manage audit logistics, and track audit findings to closure.
• Plan, schedule, and support execution of internal audits per the annual internal audit program. Draft audit checklists, compile evidence packages, and track corrective actions from audit findings.
• Monitor compliance with ISO 13485:2016, 21 CFR 820, EU MDR 2017/745, and UK MDR. Flag regulatory changes that require QMS updates and work with Quality and Regulatory teams to implement changes.
• Manage the complaint intake and tracking process in GLG. Ensure all complaints are logged, triaged, investigated, and closed within regulatory timelines.
• Track and trend postmarket surveillance data including complaints, field returns, vigilance reports, and customer feedback. Prepare periodic postmarket summaries for management review.
• Manage the training matrix and ensure all personnel complete required QMS training on time. Track training completion and issue reminders for overdue items.

Role Requirements:

• Bachelor’s degree in a scientific, engineering, or quality-related discipline (e.g., Quality Management, Biomedical Engineering, Regulatory Science, Life Sciences).
• 3 years of quality assurance or quality systems experience in an FDA-regulated, ISO 13485-certified medical device environment.
• Hands-on experience with document control and change management in an electronic QMS — Greenlight Guru experience strongly preferred; MasterControl, Veeva, or equivalent also accepted.
• Demonstrated experience supporting external audits (FDA, Notified Body, or ISO registrar) and internal audit programs.
• Working knowledge of complaint handling and CAPA processes in a medical device environment.
• Familiarity with ISO 13485:2016, 21 CFR Part 820, and EU MDR 2017/745 documentation requirements.
• Strong technical writing skills — ability to draft clear, concise SOPs and Work Instructions that hold up under regulatory scrutiny.
• Highly organized with the ability to manage multiple concurrent document workflows, audit timelines, and CAPA tracking activities without dropping threads.
• Experience with Software as a Medical Device (SaMD) or IEC 62304 environments is highly desired.