Quality Systems Specialist (Hybrid)
Core
Ensures compliance with medical device regulations (FDA 21 CFR Part 820, ISO13485) by overseeing quality programs, managing audits, and leading CAPA processes for a global healthcare technology company.
Role type
Quality Systems Specialist (Individual Contributor)
Builds
Quality assurance programs, regulatory compliance documentation, and audit readiness for medical device operations.
Domain
Healthcare Technology / Medical Devices / Regulatory Quality
Deliverable
client delivery
Required skills
Quality Management Systems (QMS) implementation, CAPA management, Root cause analysis (DMAIC), Audit preparation and execution, Regulatory interpretation (FDA/ISO), Data analysis (Excel/PowerBI), Change control processes
Preferred skills
Project Management, Process improvement methodologies
Technologies
Microsoft Excel, PowerBI
Responsibilities
Provide oversight for the development and maintenance of quality programs and procedures; Lead audit and inspection preparation and resolution of findings; Interpret regulatory regulations to assure compliance; Prepare reports and documentation such as Corrective and Preventative Actions; Coordinate legal requests in support of government investigations; Facilitate uniform standards and best practice sharing globally.
Seniority
Specialist, established individual contributor with moderate autonomy