QA Engineer (Manufacturing)
Core
Ensure manufacturing quality, compliance, and operational excellence in regulated production environments by applying quality engineering practices and supporting validation activities.
Role type
Manufacturing Quality Engineer (IC)
Builds
Reliable, high-quality medical device products
Domain
Medical device manufacturing / Quality Engineering
Required skills
Quality Systems, Manufacturing Quality, risk management, process validation, structured problem-solving, data analysis, quality planning, control strategy execution, compliance auditing
Preferred skills
Medical device industry background, MES systems, CSV/CSA, automation, advanced analytics, AI/data-driven technologies, Quality by Design
Technologies
MES, CSV, CSA, automation tools, advanced analytics platforms
Responsibilities
Support manufacturing operations to achieve quality and availability objectives; Participate in new product and process introductions ensuring embedded quality requirements; Contribute to manufacturing readiness including validation and launch support; 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 risk management and validation; Partner with engineering and operations on process and digital manufacturing changes; Support compliance activities including audits and regulatory adherence
Seniority
Mid-level, hands-on IC
