Description
\t\t\t\t\tUnder limited supervision:Position SummaryThe 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 ResponsibilitiesQuality System Separation & Stand‑UpLead 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 MigrationServe 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 & ImplementationDevelop 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 & ImprovementLead 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 ManagementMonitor 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 ComplianceEnsure all quality system changes and implementations comply with applicable global regulatory and quality standards, including:FDA 21 CFR Part 820ISO 13485:2016EU Medical Device Regulations/DirectivesJapan JPALCanada CMDCASAustralia TGAOther regional requirements based on product marketsAssess regulatory impact related to system separation, harmonization, and product transfer activities.End‑to‑End Product Lifecycle SupportApply strong knowledge of end‑to‑end medical device processes, including:Product development and design controlsDesign transferPurchasing and supplier controlsManufacturing and supply chain qualityEnsure 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.
\t\t\t\t\t\t\t\t\t\tSkills
\t\t\t\t\tProject management, windchill, iso 13485, EU, EUMDR, Quality assurance, qms, design transfer, Engineering, change management
\t\t\t\t\t\t\t\t\t\tTop Skills Details
\t\t\t\t\tProject management,windchill,iso 13485
\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tExperience Level
\t\t\t\t\tExpert Level
\t\t\t\t\tJob Type & LocationThis is a Contract position based out of Raynham, MA.
Pay and BenefitsThe 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 TypeThis is a hybrid position in Raynham,MA.
Application DeadlineThis position is anticipated to close on Feb 26, 2026.
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