QA Engineer - Patient Systems

QA Engineer - Patient Systems Ascom - 3.7 Morrisville, NC Job Details 15 hours ago Qualifications FDA submissions Incident reporting compliance Adverse event reporting Technical documentation ISO standards Engineering Production deviation management Environmental compliance Mid-level 3 years Quality control audit Patient safety Collaboration with product development teams Bachelor's degree in engineering Quality risk management Continuous improvement Product management Quality improvement Organizational skills Regulatory/legal compliance standards in production Healthcare quality audits Design controls Biomedical regulatory compliance Regulatory submissions Quality audits Cybersecurity Technical writing within technology Cross-functional team management Communication skills Product quality failure Full Job Description Hybrid - 3 days in office | Morrisville, NC Drive 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 . Why This Role Matters 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. 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 Diversity at Ascom Ascom is committed to diversity, inclusion, and equal opportunity. We value different perspectives and backgrounds and believe they help us create better solutions. At Ascom, people are judged by their skills, motivation, and potential.