Manager, Quality Systems
Core
Provide compliance oversight for local quality systems and procedures for medical device production, ensuring alignment with global and local regulations.
Role type
Manager, Quality Systems
Builds
Scalable, compliant quality systems for medical device production
Domain
Medical Devices / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Systems expertise, Corrective & Preventative Action, internal auditing, change control, document control, regulatory strategy development, audit management, stakeholder influence
Preferred skills
Lead Auditor certification, ASQ CQA certification, FDA inspection experience
Technologies
Microsoft Office (Word, Excel, PowerPoint, Access), PC SAS
Responsibilities
Develop and deliver quality compliance strategy aligned with global and local regulations; Execute and improve quality system activities including CAPA, internal audits, and document control; Monitor quality system performance and report on compliance health; Lead cross-functional internal audit programs; Represent the local quality system during regulatory and external inspections; Manage post-audit activities; Drive QMS initiatives across the organization; Partner with functional managers to maintain high-performing systems; Escalate quality system issues appropriately
Seniority
Manager, hands-on leadership