Senior Quality Engineer

About This Role

This Senior Quality Engineer role is responsible for the transfer and stand-up of a critical quality management system (QMS) during a business separation or organizational restructuring, involving PLM and quality data migration. The role ensures compliance with global regulatory standards for medical devices and drives continuous improvement.

Responsibilities

• Lead the QMS separation and stand-up, including designing and implementing a stand-alone or hybrid QMS.
• Develop strategy to extract, adapt, and/or create quality processes specific to the standalone business.
• Serve as Quality Lead for PLM team, planning and executing migration of quality system data.
• Lead mapping and migration of all quality document types, ensuring data integrity and traceability.
• Develop and implement a comprehensive quality change management strategy, including impact assessments and training.
• Ensure changes are implemented in a controlled, audit-ready manner and support organizational adoption.
• Lead quality system harmonization efforts across multiple sites or sister organizations.
• Drive continuous improvement initiatives by identifying process gaps and inefficiencies.
• Monitor overall QMS and PLM transition activities, identifying risks and implementing mitigation actions.
• Ensure all QMS changes comply with applicable global regulatory and quality standards (e.g., FDA 21 CFR Part 820, ISO 13485:2016).

Requirements

• Expert level experience with Project management
• Experience with Windchill
• Knowledge of ISO 13485
• Knowledge of EUMDR
• Strong regulatory knowledge (FDA 21 CFR Part 820, ISO 13485:2016, EU Medical Device Regulations/Directives, Japan JPAL, Canada CMDCAS, Australia TGA)
• End-to-end understanding of medical device quality systems and product lifecycle processes (development, design controls, transfer, purchasing, supplier controls, manufacturing, supply chain quality)

Qualifications

• Expert level experience in Quality Engineering, specifically with QMS and PLM in a medical device context.

Skills

* Required skills

Benefits