QA Engineer (Manufacturing)
Core
Ensure manufacturing quality, compliance, and operational excellence in regulated production environments by applying quality engineering practices, supporting validation, and driving continuous improvement.
Role type
Manufacturing Quality Engineer (IC)
Builds
Reliable, high-quality medical devices and advanced manufacturing capabilities
Domain
Medical device manufacturing / Quality Engineering
Required skills
Quality Engineering methods, Process Validation, Risk Management, Quality Planning, Data Analysis, Root Cause Analysis, Regulatory Compliance, MES systems, Automation testing, Continuous Improvement methodologies
Preferred skills
Medical device industry background, CSV/CSA knowledge, Advanced Analytics, AI for quality insights, Quality by Design (QbD)
Responsibilities
Support manufacturing operations in achieving quality and availability objectives; Participate in new product and process introductions ensuring quality requirements are embedded; Contribute to manufacturing readiness activities including validation and control strategy execution; Analyze quality data to identify trends and recommend preventive actions; Strengthen quality systems to improve Right First Time performance; Provide technical guidance and training on problem-solving and validation; Partner with engineering and operations on process and automation changes; Support digital quality and transformation initiatives; Assist with audits and adherence to Quality Management System.