Director, Quality Assurance – Medical Device Services (Multi-Site)
Core
Strategic leadership for Quality Assurance across multiple Medical Device Services sites, harmonizing QMS and ensuring regulatory compliance.
Role type
Senior Director, Quality Assurance
Builds
Harmonized Quality Management Systems (QMS) and compliant operations across multi-site laboratory and testing networks
Domain
Medical Device Services / Life Sciences / Regulatory Compliance
Deliverable
client delivery
Required skills
Strategic quality leadership, Regulatory compliance (FDA, ISO, EU MDR), QMS oversight, Audit & inspection management, Continuous improvement (Lean, Six Sigma), People management, Risk management, Data integrity, Validation concepts
Preferred skills
Master's degree in Science/Engineering/Quality, Risk Management (ISO 14971), Business Administration
Technologies
eQMS, CAPA systems, Change Control systems, Statistical analysis tools
Responsibilities
Develop and maintain harmonized QMS aligned with regulatory requirements, Lead Management Review processes and communicate metrics to executives, Serve as executive Quality representative during regulatory inspections and audits, Ensure resolution of compliance observations through corrective actions, Lead preparation and execution of FDA, ISO, and customer audits, Champion continuous improvement initiatives utilizing Lean and Six Sigma principles
Seniority
Senior, executive leadership
