Global QMS Technical Lead - Software

MEC supports medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages. MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill-set Engineering staff and SME’s (Subject Matter Experts). MEC's mission is to inspire positive cultural change from within, and always exceed our clients’ expectations.

About the role

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.

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 Stewards 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.

Requirements

• 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 Qualifications

• 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.

Schedule

Hybrid position - 3 days on-site per week.