Senior Quality Engineer

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 organization 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.

• 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, and 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. The role supports a targeted business separation timeline, with key milestones driven by quality system and PLM readiness.

• Project management experience.
• Experience with Windchill (PLM).
• ISO 13485 and EU Medical Device Regulation knowledge.
• Quality assurance and QMS expertise.
• Design transfer and engineering change management.
• Strong analytical and communication skills.
• Ability to lead cross‑functional teams.

Job Type &

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