QA Engineer - Patient Systems
Ascom · Durham, North Carolina, United States
IT Services and IT Consulting · 1,001-5,000 employees
About the role
The QA Engineer will ensure product quality and regulatory compliance across the Patient Systems portfolio throughout the product lifecycle. They will collaborate with R&D and cross-functional teams to manage risk, resolve nonconformities, and support regulatory submissions.
What they look for
Requirements
Candidates must have a bachelor's degree in Engineering, Biomedical Technology, or a related field. A minimum of 3-5 years of experience in Quality Assurance or Regulatory Affairs within a regulated industry is required.
Full description
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.
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.
