Quality Systems Manager

Job Description

Job Description

Job Title: Supplier Quality Systems Engineer

Duration: 12+ Months (Possible temp to hire)

Location: Marlborough, MA 01752

Hybrid Role

Responsibilities:

• 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.
• 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.
• 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.
• 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.
• 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.

Education/Experience:

• 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.
• 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.