QA Engineer - Patient Systems

Ascom•Durham, NC

3d•Hybrid

About The Position

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. You will be a critical contributor to product quality and regulatory compliance across Ascom’s Patient Systems portfolio. By ensuring adherence to design controls, supporting risk management, and driving resolution of product and process nonconformities, you will help safeguard patient safety, maintain regulatory confidence, and improve operational effectiveness. Your work enables teams to deliver high-quality solutions that meet both customer expectations and global compliance standards.

Requirements

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)
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

Nice To Haves

Familiarity with cybersecurity, clinical systems, and healthcare product environments is preferred

Responsibilities

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