Quality Engineer II
Core
Ensure manufacturing operations comply with Good Manufacturing Practices (GMP) and FDA/ISO standards for medical devices.
Role type
Quality Engineer II (Manufacturing)
Builds
Medical device components and technologies
Domain
Medical device manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
root-cause analysis, corrective and preventive action (CAPA), gage R&R studies, statistical process control (SPC), supplier quality management, customer complaint investigation, process validation, scrap reduction, controls planning, internal audit participation
Preferred skills
Lean QMS initiative, cost of poor quality (COPQ) reduction, engineering studies, specification clarification
Technologies
ISO 13485, 21CFR Part 820, GMP, GDP
Responsibilities
Implement root-cause analysis and CAPA for quality issues; Design and execute gage R&R studies; Lead process improvement events to reduce COPQ; Investigate customer complaints and SCARs; Conduct process and transfer validations; Prepare quality deliverables and controls plans; Participate in internal audits; Support supplier management and specification clarification.
Seniority
Mid-level, hands-on IC