Director, Quality Systems (SM)
Core
Lead the Specimen Management Quality Systems team to drive QMS processes meeting changing regulatory demands (MDR, QMSR) and align with corporate objectives.
Role type
Director, Quality Systems (Specimen Management)
Builds
Global QMS processes for medical and non-medical devices
Domain
Medical Technology / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic planning for QMS, regulatory compliance management, audit leadership, cross-functional influence, team leadership and development, change management, process improvement
Preferred skills
Knowledge of QMS software tools (Trackwise, SAP, PEGA Systems), Quality certifications (CQE, CSQE, CQA, CQM)
Technologies
Trackwise, SAP, PEGA Systems
Responsibilities
Ensure compliance with global regulatory standards for medical and non-medical devices; drive design, development, and implementation of QMS processes; act as point person for internal and external audits and inspections; coordinate external communications with regulators; lead or influence quality networks and businesses toward organizational goals; develop long-term strategy for SM QMS; manage staff and build organizational culture; operate in a matrix environment to influence senior enterprise leaders
Seniority
Director, strategic leadership & mentorship