OverviewThe Quality System Analyst plays a key role in supporting medical device compliance for emerging AR/VR and advanced technology products. In this role, you will partner closely with quality, engineering, and business teams to ensure adherence to regulatory standards throughout the entire product lifecycle.You will support product programs by executing and implementing Standard Operating Procedures (SOPs), Work Instructions (WIs), and maintaining Quality System Records from concept through end‑of‑life. This position requires experience working in regulated environments (e.g., ISO 13485, FDA QSR 21 CFR 820) and the ability to operate independently with strong attention to detail. The ideal candidate is flexible, highly organized, and comfortable managing competing priorities.ResponsibilitiesSupport Quality Management System (QMS) processes including document control, nonconformance management, CAPA, supplier qualification and monitoring, process monitoring, internal audits, and medical device product complaint handling.Create and release SOPs, WIs, templates, and records required to support new product introduction and product sustainment.Ensure all QMS documentation and data are properly controlled to maintain integrity, traceability, and accessibility.Communicate quality system requirements across Operations, Supply Chain, and Engineering teams to support compliance with applicable medical device regulations and standards.Maintain records such as validation reports, test reports, exit reviews, and test results as required by regulatory standards.Support external audits related to licensure, accreditation, and regulatory submissions.Manage and organize complex projects and priorities, troubleshoot issues affecting program progress, and provide detailed updates to cross‑functional stakeholders.Support the implementation and rollout of a new electronic Quality Management System (eQMS).Minimum Qualifications5+ years of experience managing medical device Quality Management System documentation and records in a high‑tech, fast‑paced, or consumer electronics environment.Experience with PLM or document management systems (e.g., Teamcenter or similar tools).Experience working within a regulated medical device environment.Proficiency with productivity tools such as Google Workspace or equivalent.Familiarity with ISO 13485 standards and related regulatory frameworks. EEO EmployerApex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at
[email protected] or 844-463-6178.