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 Assurance Engineer
Builds
Reliable, high-quality medical device products
Domain
Medical device manufacturing / Quality Engineering
Required skills
Quality Engineering methods, Risk management, Process validation, Quality planning, Data analysis, Root cause analysis, Regulatory compliance, Continuous improvement methodologies
Preferred skills
Medical device industry experience, MES systems, Digital quality systems, Automation, Advanced analytics, AI technologies
Technologies
MES, CSV/CSA, Automation tools, Data analytics platforms
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 digital manufacturing changes; Support compliance activities including audits and regulatory adherence.