Leads and Coordinates and ensures compliance to CAPA, HHA and NCE systems.
Designs and applies company policies and procedures that help Dexcom achieve its quality policy and compliance with domestic and international regulations.
Participates in internal audits, supplier audits to ensure systems comply with requirements and are effective.
Lead the development and execution of Care Access’s quality program across clinical, operational, and technology domains.
Build and maintain a risk-based, fit-for-purpose Quality Management System (QMS) that supports Care Access’s mission.
Collaborate with Operational Compliance, Product, Privacy, IT, and other functional partners to embed quality by design across systems and workflows.
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, they bring world-class research and health services directly to communities that often face barriers to care.
Support software validation and verification efforts to ensure compliance with FDA regulations and industry standards.
Own the quality approval process for software components, including documentation review and final release approvals.
Partner with the software engineering team to implement and maintain a robust software quality management system.
Sequel, headquartered in Manchester, New Hampshire, is developing the next generation of transformative drug-delivery advancements starting with diabetes. Sequel’s approach is to look at diabetes management holistically to advance systems that make living with diabetes simpler and easier for all. Sequel provides equal employment opportunities and believes that when you thrive, they thrive.
Conduct remote audits of medical device manufacturers’ Quality Management Systems under ISO 13485, EU MDR, and UK MDR.
Provide clear, structured audit documentation and evidence-based conclusions.
Contribute to consistent, high-quality audit experiences aligned with Scarlet’s audit methodology and values.
Scarlet is authorized by governments to assess and grant market access to medical AIs, enabling innovative technology to reach patients safely and quickly. They are considered the pre-eminent authority on AI medical devices, serving well-resourced and ambitious companies.
Develop and report key quality metrics across all clinical programs and trials.
Ensure compliance with GCP, ICH-GCP, FDA, EMA, PMDA, and applicable regulations.
Drive inspection readiness at local and global levels.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. Their core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of their business.
Drive execution of NPI strategy to develop scalable, high-yield processes.
Optimize inspection strategies through technology, automation, and supplier certification.
Coach and develop a team of quality engineers to meet performance metrics.
Stryker is a leading medical technology company committed to improving healthcare. They offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine. They are proud to be named one of the World’s Best Workplaces!
Support registrations, submissions, and lifecycle maintenance activities.
Help maintain and improve QMS processes and records to support ISO 13485 certification.
Receive, log, review, and route product complaints for investigation.
Dandy is transforming the antiquated dental industry through technology. Backed by leading venture capital firms, Dandy is building the operating system for dental offices around the world—empowering clinicians and their teams to achieve more for their practices, their people, and their patients.
Partner in optimizing and streamlining design control requirements for medical devices.
Lead process development and improvement projects with cross-functional teams globally.
Conduct and develop training on design controls and related process changes.
Jobgether is a company that uses AI-powered matching to ensure applications are reviewed quickly and fairly. They identify the top-fitting candidates and share this shortlist with the hiring company.