Senior Engineer, Quality
Core
Senior Quality Engineer applying quality engineering principles to maintain compliant manufacturing processes, resolve complex product quality and compliance issues, and drive continuous improvement in a regulated medical device environment.
Role type
Senior IC manufacturing quality engineer
Builds
compliant medical device manufacturing processes and quality systems
Domain
Medical device manufacturing / Quality Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
root cause analysis, risk management, statistical data analysis, process optimization, technical reporting, cross-functional leadership, training and coaching
Preferred skills
GDP/GMP proficiency, FDA QSR/21 CFR Part 820/ISO 13485/ISO 14971/EU MDR awareness, inspection and measurement tools operation, SPC/Minitab proficiency, process/equipment qualification and validation, AI-enabled applications usage
Technologies
Minitab, MS Office Suite, digital productivity tools, AI-enabled applications
Responsibilities
Investigate complex manufacturing product quality and compliance issues, determine root causes, and initiate/review reports; Lead cross-functional teams to align on root cause, risk impact, containment, and corrective actions; Develop and maintain risk management files and procedures; Lead technical studies and author technical reports; Optimize complex manufacturing processes using Six Sigma and Lean; Train, coach, and guide peers and junior employees
Seniority
Senior, hands-on IC
