Sr. Quality Systems/CAPA Engineer
Core
Ensures product compliance with quality standards and establishes compliance with the quality system for medical devices.
Role type
Senior Quality Systems/CAPA Engineer
Builds
Quality system infrastructure, performance metrics, and compliance reports for medical devices
Domain
Healthcare / Medical Devices / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality tools/methodologies, FDA 21 CFR 820, GMP, ISO 13485, ISO 14971, trend analysis, root cause analysis, CAPA management, audit participation, risk assessment
Preferred skills
Project management, multi-departmental team leadership, internal/external audit experience, statistical/data analysis, medical device industry experience, ASQ CQE or CQA certification
Technologies
None explicitly stated
Responsibilities
Assure compliance with corporate and divisional requirements regarding metrics reporting for Management Controls and CAPA; Complete trend analysis of data to determine proper actions; Perform and assure timely follow-up activities in support of key quality and compliance goals; Identify and implement opportunities for continuous improvement; Represent Quality Systems in support of cross-functional projects; Assist in company preparations for hosting external audits; Lead non-conformance investigation teams to identify root causes and effective CAPAs; Function as part of risk assessment teams to identify product, quality system and compliance requirements
Seniority
Senior, hands-on IC with mentorship responsibilities