Own and continuously improve the Quality Management System for simulation products, programs, and services.
Serve as the primary quality liaison for customers, suppliers, and subcontractors, ensuring requirements flow down and are met.
Drive risk-based audits, CAPA activities, and root-cause analysis to improve quality performance and compliance.
Aechelon Technology, a Shield AI company, produces 3D simulator content including geospecific visual/sensor databases and realistic 3D models for pilot training. The company seeks passionate people committed to real-time computer graphics and the mission of improving pilot safety.
Review and approve validation of software and AI products to ensure full compliance with regulatory requirements and company policies.
Prepare for and support external regulatory audits; lead internal or vendor audits related to maintaining GxP and regulatory compliance.
Develop and maintain digital/software components of quality management systems, including AI quality management systems.
Care Access brings world-class research and health services directly to communities that often face barriers to care. With hundreds of research locations, mobile clinics, and clinicians across the globe, they are reimagining how clinical research and health services reach the world.
Ensure product complaint investigations and procedures comply with FDA QSR, ISO, and Medical Device Directives for Vigilance.
Perform FTIR analysis and program mechanical lab equipment such as Chatillon to support material identification and complaint investigations.
Provide audit support and enforce compliance with equipment maintenance, hazmat, biohazard, and disposal management protocols.
Embecta is a global medical device company with a 100-year legacy in insulin delivery and diabetes care. We are expanding our portfolio of solutions to serve more patients, healthcare providers, and communities worldwide.
Lead GCP quality for clinical studies as the primary Quality point of contact from start-up through close-out.
Build the GCP quality framework, authoring SOPs, quality plans, and risk management aligned with ICH E6(R3).
Qualify and audit CROs, clinical sites, and vendors, and partner on inspection readiness.
Osanni Bio is a development-stage therapeutics platform headquartered in San Francisco, California, advancing programs in ophthalmology, cardiology, and beyond. They are a creative, agile team of innovators guided by core values of integrity, impact, agility, and collaboration.
Lead and supervise a team of regulatory specialists managing labeling approvals, drug listings, and medical device submissions.
Oversee FDA compliance, quality investigations, and health hazard evaluations to ensure product integrity.
Collaborate cross-functionally with Quality Assurance, Legal, and external partners to resolve complex regulatory challenges.
The partner company is a pharmaceutical and medical device organization focused on ensuring regulatory compliance and product quality. The company fosters a collaborative and inclusive work environment, emphasizing continuous improvement and professional development.
Prepare and maintain core medical device training courses, including MDR/IVDR/ISO13485/MDSAP.
Support peer reviews and assessments for trainee exercises to ensure conformity assessment understanding.
Schedule training sessions and track the progression and qualification status of new trainees.
SGS is the world's leading testing, inspection and certification company, recognized as a global benchmark for sustainability and quality. With 99,600 employees across 2,600 offices, we offer a dynamic, international culture and long-term development opportunities.
Drive data-driven supplier selection and engagement for client programs, monitoring performance quality and delivery.
Lead communication and onboarding of suppliers to new client programs, ensuring capacity and skill alignment.
Track SLAs, manage device logistics and compliance, and support continuous improvement through automation and reporting.
Welocalize serves localization teams through AI-enabled multilingual content solutions, enabling enterprises to operate globally in over 300 languages. The company combines AI, automation, and human expertise within a secure environment, is headquartered in New York, and has offices worldwide.