Quality System Engineer

Global Quality Management Systems Engineer and Project Management Candidates must be W2 or C2C, no 3rd party and no candidates requiring visa sponsorship. Location: Hybrid, 3 days/week on-site in Marlborough, MA. Length: 12 month contract Summary: Candidate will provide dedicated support for strategic Global Quality Systems initiatives by assessing, designing, implementing, and continuously improving enterprise Quality Management System (QMS) processes governing Supplier Controls and Sourced Device & Material Controls. This role supports implementation of evolving global regulatory requirements for Sourced Finished Medical Devices (SFMD), including embedded and associated software, Software as a Medical Device (SaMD), cybersecurity, Artificial Intelligence (AI), digital health, medical device components, and other outsourced products and services. Candidate will serve as the dedicated lead for supplier-related QMS process enhancements across multiple enterprise initiatives. Partnering closely with the Global Process Steward(s) for Supplier Controls and Sourced Device & Material Controls, this role will support the evaluation and prioritization of strategic initiatives, translate business and regulatory requirements into process enhancements, and lead implementation to ensure consistent, sustainable execution of Supplier Controls and Sourced Device & Material Controls that support emerging digital technologies and evolving global regulatory expectations. Working across Global Supplier Quality, Global Quality Systems, Global Sourcing, Regulatory Affairs, Legal, Cybersecurity, Software Engineering, Digital Health, Information Technology, and Research & Development, the Technical Process Lead will provide technical leadership, process leadership, and project coordination to drive supplier quality system enhancements from concept through implementation. The successful candidate will proactively identify process gaps, facilitate cross-functional alignment, drive technical and process decisions, manage implementation activities, and ensure project milestones and deliverables are achieved while delivering sustainable QMS improvements. Duties/Responsibilities: Lead the assessment, design, implementation, and continuous improvement of Supplier Controls and Sourced Device & Material Controls processes supporting technology suppliers, Sourced Finished Medical Devices (SFMD), medical device component suppliers, OEMs, Contract Manufacturers, and other outsourced providers. Partner with the Global Process Steward(s) to provide technical and process leadership for strategic Quality Management System initiatives. Collaborate to assess business and regulatory needs, prioritize process enhancements, establish implementation roadmaps, and drive execution of Supplier Controls and Sourced Device & Material Controls improvements across the enterprise. Drive cross-functional implementation by facilitating workshops, coordinating stakeholders, managing action items, resolving issues, and ensuring supplier quality initiatives progress according to project objectives and timelines. Assess and enhance supplier assessment and supplied device/material qualification processes, supplier lifecycle management, supplier change management, supplier remediation, supplier risk management, and the Supplier Change Impact Assessment (SCIA) process, ensuring supplier controls appropriately address software, cybersecurity, AI-enabled technologies, cloud services, digital health, and evolving regulatory expectations. Develop, revise, and implement QMS procedures, work instructions, templates, forms, quality records, and supporting documentation to establish sustainable, inspection-ready supplier quality processes. Enhance responsibility allocation matrices (e.g., RACI/QPTP) and quality ownership models for Contract Manufacturers (CM), Contract Design Manufacturers (CDM), Original Equipment Manufacturers (OEM), OEM+ models, and technology suppliers. Define and document responsibilities associated with software design and development, software design transfer, AI development and lifecycle activities, cybersecurity, software lifecycle activities, risk management and risk transfer, supplier oversight, post-market cybersecurity, and change management. Collaborate with Global Sourcing, Legal, Regulatory Affairs, and Quality stakeholders to update quality agreements, supplier agreements, and QMS-related contractual requirements to reflect evolving quality, regulatory, software, cybersecurity, AI, design control, supplier oversight, and post-market responsibilities. Support supplier remediation activities, internal audits, regulatory inspections, and Quality System initiatives by implementing sustainable process improvements and maintaining inspection-ready documentation. Monitor emerging regulations, standards, and industry guidance and translate new requirements into practical, risk-based enhancements to Supplier Controls and Sourced Device & Material Controls processes. Qualifications/Requirements: Required: Bachelor's degree in Engineering, Quality, Computer Science, Cybersecurity, Software Engineering, Information Systems, Life Sciences, or a related technical discipline. 5 or more years of experience in Quality Systems, Supplier Quality, Supplier Controls, Sourced Device & Material Controls, Regulatory Compliance, or related quality functions within a regulated industry. Demonstrated experience assessing, designing, implementing, and improving QMS processes, including supplier assessments, supplier controls, supplier documentation, quality agreements, responsibility allocation matrices, and outsourced process controls. Experience supporting software suppliers, cloud service providers, technology suppliers, SFMD suppliers, component suppliers, OEMs, Contract Manufacturers, or other outsourced providers. Strong understanding of supplier assessments, supplier lifecycle management, supplier responsibility models, outsourced process controls, risk-based quality principles, and QMS documentation. Working knowledge of FDA 21 CFR Part 820/Quality Management System Regulation (QMSR), ISO 13485:2016 (including supplier, purchasing, and outsourced process controls), ISO 14971, FDA inspection and MDSAP expectations, 21 CFR Part 11, FDA Computer Software Assurance (CSA), and applicable FDA post-market requirements. Familiarity with EU MDR/IVDR, IEC 62304, IEC 82304-1, IEC 81001-5-1, FDA software and cybersecurity guidance, IMDRF SaMD guidance, AI/ML regulatory and risk management frameworks, and quality system expectations for emerging digital technologies. Demonstrated ability to independently lead cross-functional initiatives, influence stakeholders, facilitate decision-making, manage multiple priorities, and deliver complex process improvements in a global, matrixed organization. Excellent communication, facilitation, organizational, and project management skills. Preferred: Experience in the medical device or other regulated healthcare industry. Experience implementing enterprise Quality Management System improvements or large-scale compliance initiatives. Experience supporting Supplier Controls and Sourced Device & Material Controls for software, cybersecurity, AI-enabled technologies, digital health, cloud services, SaMD, SFMDs, medical device components, OEMs, Contract Manufacturers, or other outsourced providers. #J-18808-Ljbffr Redbock - an NES Fircroft company