Hybrid - 3 days in office | Morrisville, NCDrive product quality. Strengthen compliance. Enable safer patient care.Join Ascom's quality organization as a
QA Engineer, Patient Systems and play a key role in ensuring the quality, compliance, and reliability of our healthcare solutions. This role focuses on supporting product quality across the lifecycle-working closely with R&D, regulatory, and cross-functional teams to uphold Ascom's Integrated Management System while enabling efficient and compliant product development.
This position requires three days in the office.
What You'll Own- Ensure quality compliance of assigned products and services-including third-party components-across the full product lifecycle in alignment with design controls and regulatory requirements
- Support the review of design and process changes for completeness, accuracy, and compliance with quality system and regulatory standards
- Partner with R&D to maintain accurate, complete, and up-to-date technical documentation
- Participate in product risk management activities and provide quality input to project teams
- Manage product nonconformities (e.g., NCRs), guiding cross-functional teams to ensure timely resolution
- Support and, when assigned, lead field corrective actions and product recalls
- Contribute to regulatory submissions (e.g., FDA 510(k), EU MDR) by ensuring quality and compliance requirements are met
- Support the development, implementation, and continuous improvement of the Ascom Integrated Management System
- Provide QA guidance to cross-functional teams to ensure products and processes meet regulatory and internal standards
- Participate in audits and support compliance activities across quality and regulatory functions
- Ensure adherence to environmental, health, safety, and compliance reporting requirements, including nonconformities and incidents
What Sets You Up for Success- Bachelor's degree in Engineering, Biomedical Technology, or a related scientific field, or equivalent experience
- 3-5 years of experience in Quality Assurance or Regulatory Affairs within a regulated industry
- Strong knowledge of quality systems and regulatory frameworks (e.g., FDA QSR, ISO, MDR/MDD)
- Understanding of medical device regulations, including software and risk management standards (e.g., IEC 62304, ISO 14971)
- Familiarity with cybersecurity, clinical systems, and healthcare product environments is preferred
- Ability to collaborate cross-functionally with R&D, quality, and customer-facing teams
- Strong attention to detail with the ability to manage documentation, compliance activities, and process improvements
- Excellent communication and organizational skills
Department Legal, Quality & Regulatory Locations US Raleigh Remote status Hybrid
