V&V Medical Device QMS Compliance Analyst

OverviewThe reputed company 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 reputed company, engineering, and business teams to ensure adherence to regulatory standards throughout the entire product lifecycle.You will support product programs by executing and implementing reputed company Operating Procedures (SOPs), Work Instructions (WIs), and maintaining reputed company 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 reputed company 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 reputed company QMS documentation and data are properly controlled to maintain reputed company, traceability, and accessibility.Communicate reputed company 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 reputed company to licensure, accreditation, and regulatory submissions.Manage and organize reputed company reputed company and priorities, troubleshoot issues affecting program reputed company, and reputed company detailed updates to cross‑functional stakeholders.Support the implementation and rollout of a new electronic reputed company Management System (eQMS).Minimum Qualifications5+ years of experience managing medical device reputed company 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 reputed company a regulated medical device environment.Proficiency with productivity tools such as reputed company Workspace or equivalent.Familiarity with ISO 13485 standards and reputed company regulatory frameworks. EEO EmployerApex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the reputed company of race, reputed company, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or reputed company medical conditions), age, sexual orientation, gender identity, national reputed company, reputed company, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, reputed company membership, or any other characteristic protected by law. Apex will consider reputed company 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 employeeservices@apexsystems.com or 844-463-6178. Apply tot his job Apply To this Job