QA Engineer Patient Systems

Hybrid Morrisville NC

Drive product quality. Strengthen compliance. Enable safer patient care.

Join Ascoms 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 lifecycleworking closely with R&D regulatory and cross-functional teams to uphold Ascoms 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 Ascoms 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 Youll Own

• Ensure quality compliance of assigned products and servicesincluding third-party componentsacross 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

• Bachelors degree in Engineering Biomedical Technology or a related scientific field or equivalent experience

• 35 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.