Description Under limited supervision: Position Summary The Senior Quality Management System Engineer will be responsible for transferring a stand‑alone quality management system (QMS) as part of a business separation or organizational restructuring. This role leads quality system and PLM change management activities, ensuring compliant extraction, migration, and consolidation of quality processes, documentation, and product data from a shared or embedded environment into a new or hybrid QMS. The position requires strong regulatory knowledge, cross‑functional leadership, and end‑to‑end understanding of medical device quality systems. Key Responsibilities Quality System Separation & Stand‑Up Lead the design and implementation of a stand‑alone or hybrid quality management system that is currently embedded within a larger parent organization’s quality framework. Develop a deep understanding of the existing, intertwined quality system and define the strategy to extract, adapt, and/or create quality processes specific to the standalone business. Establish governance, structure, and ownership for the new quality system, ensuring operational continuity throughout the transition. PLM & Quality Data Migration Serve as the Quality Lead working closely with the PLM (Product Lifecycle Management) team to plan and execute the migration of quality system data into a new system container. Lead mapping and migration of all quality document types, including procedures, work instructions, specifications, parts, forms, records, and related metadata. Ensure document control, traceability, version history, and data integrity are maintained throughout the PLM transition. Manage dependencies between the quality system transition and PLM system timing to support project milestones. Change Management & Implementation Develop and implement a comprehensive quality change management strategy, including impact assessments, communication plans, training considerations, and phased rollout. Support organizational adoption of new or revised quality processes, tools, and system workflows. Ensure changes are implemented in a controlled, audit‑ready manner. Quality System Harmonization & Improvement Lead quality system harmonization efforts across multiple sites or sister organizations, including consolidation of previously separate quality systems where applicable. Drive continuous improvement initiatives by identifying process gaps, redundancies, or inefficiencies. Develop quality plans and project plans, and maintain detailed project schedules to track progress and dependencies. Project Oversight & Risk Management Monitor overall quality system and PLM transition activities, identifying risks, issues, and bottlenecks. Proactively recommend and implement mitigation actions to keep the project on schedule and compliant. Provide regular status updates to internal project leadership and key stakeholders. Regulatory Compliance Ensure all quality system changes and implementations comply with applicable global regulatory and quality standards, including: FDA 21 CFR Part 820 ISO 13485:2016 EU Medical Device Regulations/Directives Japan JPAL Canada CMDCAS Australia TGA Other regional requirements based on product markets Assess regulatory impact related to system separation, harmonization, and product transfer activities. End‑to‑End Product Lifecycle Support Apply strong knowledge of end‑to‑end medical device processes, including: Product development and design controls Design transfer Purchasing and supplier controls Manufacturing and supply chain quality Ensure product and quality records remain complete, compliant, and inspection‑ready during and after system transitions. Role supports a targeted business separation timeline, with key milestones driven by quality system and PLM readiness. Skills Project management, windchill, iso 13485, EU, EUMDR, Quality assurance, qms, design transfer, Engineering, change management Top Skills Details Project management,windchill,iso 13485 Experience Level Expert Level Job Type & Location This is a Contract position based out of Raynham, MA. Pay and Benefits The pay range for this position is $70.00 - $71.11/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in Raynham,MA. Application Deadline This position is anticipated to close on Feb 26, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.