Quality Engineer II
Core
Ensure manufacturing operations comply with Good Manufacturing Practices (GMP), FDA standards, and ISO 13485 regulations for medical devices.
Role type
Quality Engineer II
Builds
Medical device components and technologies
Domain
Medical device manufacturing
Required skills
root-cause analysis, corrective and preventive action (CAPA), gage R&R studies, supplier quality management, process validation, statistical process control (SPC), scrap reduction, customer complaint investigation, internal audit participation, specification clarification
Preferred skills
Lean QMS initiative, cost of poor quality (COPQ) reduction, controls plan creation, engineering studies execution
Technologies
ISO 13485, 21CFR Part 820, GMP, GDP, SCAR process, SPC
Responsibilities
Participate in multidisciplinary teams to implement root-cause analysis and CAPA; Design, execute, and document gage R&R studies; Lead process improvement events to reduce cost of poor quality; Reduce scrap and manufacturing waste; Act as Quality Representative for Material Review Board and Process Validations; Conduct and follow up on SCAR processes; Investigate and respond to customer complaints; Prepare quality-related deliverables and engineering studies; Implement SPC; Eliminate escapes to the customer; Create controls plans; Support supplier management and internal audit teams.
Seniority
Mid-level, hands-on IC