Overview In this role you will oversee the global QMS implementation and continuous improvement to meet medical device regulations. You will partner with cross-functional teams to harmonize procedures across sites, perform gap assessments, and update local processes to stay compliant. The position balances regulatory rigor with practical quality improvements, enabling safer products and aligned operations. You will help shape quality strategy within a global framework and drive consistent, risk-based quality practices.
Responsibilities- Harmonize quality procedures, tools, and best practices across sites and regions
- Conduct gap assessments of local procedures against corporate requirements and regulatory standards
- Collaborate to update local procedures to align with applicable requirements
- Support cross-functional teams to implement improvements within the QMS
- Contribute to the establishment and maintenance of compliant processes across the organization
Key requirements- Extensive knowledge of global regulatory requirements for medical devices (21 CFR 820, ISO 13485, EU MDR, ISO 14971)
- Experience developing and implementing QMS elements (purchasing controls, design controls, nonconformance, validation, CAPA)
- Familiarity with quality tools and methodologies (Six Sigma, root cause analysis, risk management, SPC, FMEA)
- Strong communication and stakeholder influence across R&D and Regulatory
- Experience with ERP/QMS systems (e.g., SAP, EtQ)
- Previous medical device experience; SaMD and class II devices preferred
- 5+ years in Quality/Regulatory Compliance; CQE or equivalent preferred
- MS Office proficiency
- strong communication
- collaboration
- influence across diverse stakeholders
- Six Sigma
- root cause analysis
- risk management
