Key Responsibilities

• Oversee the quality aspects of Software as a Medical Device (SaMD) product development, including design controls, software lifecycle processes, verification and validation, product release, and design transfer.
• Ensure traceability is maintained between user requirements, specifications, risk management controls, test cases, and their outcomes.
• Assist in the preparation and upkeep of the Design History File (DHF) and related technical documentation to guarantee readiness for audits.
• Lead ISO 14971 risk management efforts, which encompass hazard assessments, risk evaluations, control implementations, residual risk analyses, and cybersecurity assessments.
• Manage the Risk Management Files and ensure that risk updates are made throughout the entire product lifecycle.
• Take ownership or provide support for key Quality Management System (QMS) processes, including Corrective and Preventive Actions (CAPA), complaint resolution, nonconformance management, document control, and ongoing improvement initiatives.
• Conduct investigations, perform root cause analyses, implement effectiveness checks, and carry out compliance assessments within established timelines.
• Assist with internal audits, regulatory inspections, and external audits (including FDA, Notified Body, MDSAP, and ISO 13485).
• Execute gap analyses and integration activities for newly acquired products, QMS processes, and design documentation.
• Serve as the quality lead for designated product teams, offering compliance guidance and escalating quality-related risks as necessary.

Essential Qualifications, Education & Experience

• Bachelor's degree in a relevant field or equivalent professional experience.
• 3 to 7+ years of experience within a regulated sector, with a preference for those possessing medical device and SaMD expertise.
• In-depth knowledge of EU MDR 2017/745, ISO 13485, ISO 14971, IEC 62304, IEC 82304, IEC 81001-5-1, and FDA Quality System/Quality Management System requirements, including 21 CFR Part 11 and 21 CFR Part 820.
• Familiarity with software development lifecycles, Agile methodologies, and the application of design controls in software development processes.
• Experience with regulatory, certification, or quality system audits is a plus.
• Exceptional written and verbal communication abilities, capable of producing clear, compliant, and defensible quality documentation.
• Strong attention to detail, effective organizational skills, and the capability to handle multiple priorities simultaneously.