Quality Auditor
Core
Ensure management systems enable business compliance with regulatory frameworks and support the design, development, and manufacture of medical devices meeting customer quality requirements.
Role type
Quality Auditor (Medical Devices)
Builds
Supplier quality systems, audit programs, and CAPA processes for medical device manufacturing.
Domain
Medical Devices / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Systems knowledge, audit experience, project management, regulatory compliance analysis, stakeholder liaison, process improvement, supplier management
Preferred skills
Six Sigma training, analytical problem-solving, ISO13485 knowledge, FDA 21 CFR Part 820 knowledge, leading internal and supplier audits
Technologies
ISO 13485, FDA 21 CFR Part 820, MDSAP
Responsibilities
Support preparation and implementation of supplier and internal audit programs; Provide reports to management on audit and CAPA status; Project manage activities resulting from audit observations and non-conformances; Review and interpret audit observation activities and CAPA evidence; Support and represent the company in external audit situations; Recommend opportunities for continual improvement of the audit system; Work with QA teams to ensure global alignment of Quality Systems; Support maintenance of QA supplier management and monitoring activities.
Seniority
Mid-level, hands-on IC