Senior Manager, Quality Engineering - Software

• Build & Develop Teams: lead, coach, and develop a team of quality professionals and establish a culture of quality amongst the team and collaborative nature while partnering with stakeholders across the organization.
• QMS Development & Global Compliance:
• Ensure product development and product sustaining activities comply with regulatory standards including FDA revised 21 CFR Part 820 (QMSR), EU MDR 2017/745, ISO 13485, IEC 62304/82304, ISO 14971, and IEC 62366, and other applicable guidances related to all products, including active implantable medical devices and software as a Medical Device (SaMD).
• Maintain and continuously improve a scalable QMS to comply with regulatory requirements (U.S. FDA, EU MDR, TGA) and industry best practices, including creation and maintenance of Software Development Lifecycle (SDLC) procedures and work instructions.
• Support and contribute to execution of risk management activities in compliance with ISO14971 and software risk requirements in IEC 62304.
• Support efforts for cybersecurity and security risk management for both US and global requirements, as applicable where product is commercialized.
• Manage trend monitoring and CAPA system, including root cause analysis and effectiveness checks.
• Design Controls:
• Lead Design Control and Software Development Quality projects and initiatives to ensure Design History File documents for Class III medical devices, mobile medical applications (MMAs), cloud-based systems, and cybersecurity controls meet regulatory expectations for premarket submissions and audits. This includes providing timely guidance and expertise during creation and review of software development artifacts such as software requirements, architecture, design documentation, risk management, planning documentation, V&V protocols/reports, and release notes; and evaluating design updates and impact assessments for software updates.
• Provide guidance on and participate in development activities including design reviews, risk reviews, requirements analysis and tracing, defect tracking and investigation, and configuration management.
• Supplier Management & Audit Support:
• Responsible for supporting supplier quality management, ongoing performance monitoring, receiving inspections, NCMRs, and supplier audits.
• Establish and maintain supplier quality frameworks for software vendors, cloud providers, and contract manufacturers.
• Leading efforts and team for both internal and external audits, including FDA inspections and notified body audits.
• Working knowledge of data privacy requirements in U.S. and EU (GDPR) desired.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change. To find out more about Real, please visit www.realstaffing.com