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.
Develops and drives regulatory strategy for FDA Pharma and IVDR initiatives.
Represents the regulatory function on cross-functional teams and interacts with regulatory authorities.
Coordinates regulatory submissions and ensures compliance with global requirements.
Natera is a clinical genetic testing company specializing in non-invasive cell-free DNA and liquid biopsy testing. The team consists of highly dedicated professionals from world-class institutions who care deeply for their work and each other.
Provide scientific, strategic, and commercial leadership for Product Safety Labs' medical device biocompatibility business.
Collaborate with Study Directors, laboratory management, and business development to strengthen scientific capabilities and expand service offerings.
Represent PSL through client engagement, scientific presentations, publications, and standards committees.
Eurofins Scientific is an international life sciences company providing analytical testing services to make life and our environment safer, healthier and more sustainable. With over 58,000 staff across 900 laboratories in more than 54 countries, Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing.
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.
Install, maintain, troubleshoot, and support Waters' product suite (LC, LC/MS, HPLC/UPLC, SFC).
Build customer relationships, manage expectations, and provide system-level training.
Ensure compliance with quality and safety standards and document work daily.
Waters Corporation is a global leader in life sciences and diagnostics, providing analytical technologies and services. With approximately 16,000 employees, it fosters an innovative culture that turns scientific challenges into breakthroughs.
Serve as a technical lead and device subject matter resource across the medical device total product life cycle.
Analyze premarket and postmarket submissions, evaluating safety, effectiveness, and benefit-risk determinations.
Develop SOPs, real-world evidence protocols, and risk standards grounded in FDA guidance while mentoring junior engineers.
ICA, Inc. is a rapidly growing government consulting firm providing innovative solutions in public health research, advanced data science, and strategic services. Our small but collaborative team prioritizes work-life balance and supports dynamic, highly skilled professionals.
Oversee GCP compliance, manage deviations and CAPAs, and conduct quality and TMF reviews.
Maintain inspection readiness and support CRO oversight per ICH E6(R3).
Collaborate with Data and Clinical teams to embed compliance into workflows and train teams.
Resilience Care is a French medtech founded in 2021, offering AI remote monitoring for oncology, gastroenterology, and psychiatry. It serves 35,000 patients across 200+ facilities with an agile, collaborative culture.
Own the full post-sale journey for Kivo's customers, driving outcomes, retention, and expansion.
Lead end-to-end implementations of the Kivo platform, from solution design and configuration to validation and go-live support.
Serve as strategic partner and primary account point of contact, managing account health and partnering with Sales on expansion opportunities.
Kivo is a life-sciences SaaS platform specializing in quality management for pharmaceutical, biotech, and medtech organizations. It is a hyper-growth, fast-paced company focused on delivering customer success in regulated environments.
Perform advanced troubleshooting, repair, and maintenance of complex medical equipment at customer sites.
Lead and mentor less experienced field engineers while serving as an escalation point for customer issues.
Partner with customers and commercial teams to drive service quality and support business growth.
GE HealthCare is a global medical technology company partnering with customers to fulfill healthcare's potential through groundbreaking medical devices and care solutions. We offer a collaborative work environment with professional development and competitive compensation.
Lead hands-on field failure investigations on medium voltage transformers, switchgear, and converters, including site inspection and teardown.
Apply the 8D method to determine evidence-based root causes and drive corrective actions across the product lifecycle.
Collaborate with cross-functional and international teams, including SMA's global headquarters in Germany, to implement and verify sustainable solutions.
We are the U.S. subsidiary of SMA Solar Technology AG, developing solar inverter solutions for every system size, backed by more than 1,500 patents and a presence in over 190 countries. We invest in our people, foster a collaborative culture, and give employees real autonomy to take ownership of their work.
Execute the clinical audit program, including scheduling, planning, reporting, and resolution of audits.
Ensure compliance with worldwide regulations, ICH-GCP, AbbVie policies, and sponsor requirements.
Provide advice and support on GCP and quality topics to business partners and support inspections.
AbbVie discovers and delivers innovative medicines and solutions across immunology, oncology, neuroscience, and aesthetics. It is a large biopharmaceutical company committed to integrity, innovation, and community service.