Director, Process Compliance & Centers of Excellence
Core
Spearhead strategic development and deployment of enterprise quality controls and process improvements, leading organization-wide compliance initiatives and analyzing data for trends and risks.
Role type
Director, Quality Compliance & Process Excellence
Builds
Robust enterprise quality controls, process improvement frameworks, and compliance programs for medical device manufacturing and R&D.
Domain
Medical Devices / Quality Management Systems (QMS)
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
FDA 21 CFR Part 820, ISO 13485, EUMDR, Risk Management (ISO 14971), PFMEA, root cause analysis, CAPA process, Internal Audit, New Product Introduction (NPI) validations, Cost of Poor Quality (COPQ) analysis, talent management, succession planning, regulatory inspection leadership, strategic process validation, cross-functional leadership.
Preferred skills
MBA, MS, or equivalent advanced degree.
Technologies
None explicitly stated.
Responsibilities
Drive strategic initiatives to elevate supplier quality standards; guide setup of acceptance activities and NPI validations; analyze data to identify trends, risks, and improvement opportunities; manage compliance with industry regulations and oversee documentation; lead talent management and succession planning; authorize assessment of impact to PFMEA and associated controls; mentor quality engineers and cultivate a culture of continuous learning.
Seniority
Director, strategic leadership & mentorship