The Quality Leader is responsible for leading the organization's quality management system to ensure products meet internal standards, customer requirements, and regulatory obligations
Job Summary
The Quality Leader is responsible for leading the organization's quality management system to ensure products meet internal standards, customer requirements, and regulatory obligations.
This role provides strategic leadership for quality assurance and control activities while driving continuous improvement initiatives across manufacturing operations.
The position requires overseeing ongoing manufacturing QA/QC in ISO 7 cleanroom environments and partnering with cross-functional teams to embed quality into operational processes.
Matching Summary
The Quality Leader is responsible for leading the organization's quality management system to ensure products meet internal standards, customer requirements, and regulatory obligations.
Skills & Requirements
Must-have
Lead quality management system compliance
Manage ISO 9001 and regulatory requirements
Oversee ISO 7 cleanroom manufacturing QA/QC
Drive root cause analysis and CAPA processes
Lead internal and external audits
Nice-to-have
Experience in life sciences or medical device
ISO 13485 certification knowledge
Lean Six Sigma formal training
Influence cross-functional partners effectively
Culture of inspiring teammates
Key Requirements
Bachelor's degree in Engineering, Quality, or Life Sciences
Minimum 5 years progressive experience in quality leadership
Demonstrated experience with ISO 9001 systems
Strong knowledge of auditing, CAPA, and regulatory compliance