Operations Quality Engineer II
Core
Support the Operations Quality function within Advanced Surgical Instruments (ASI) to ensure product quality, process performance, and compliance across production operations for stapling product families.
Role type
Mid-level IC operations quality engineer
Builds
Quality systems, inspection/testing strategies, and corrective actions for medical device manufacturing
Domain
Medical device manufacturing / Surgical instruments
Required skills
root cause analysis, CAPA implementation, quality system compliance, data analysis, process validation, cross-functional collaboration
Preferred skills
Lean/Six Sigma methodologies, QSR/ISO 13485 knowledge, statistical problem-solving tools, ASQ CQE certification
Technologies
None explicitly stated
Responsibilities
Develop and implement inspection, testing, validation, and monitoring strategies; Execute root cause investigations and verify corrective actions; Analyze quality, process, and production data to identify trends; Partner with manufacturing and engineering to establish quality standards; Support regulatory and external audit readiness
Seniority
Mid-level, hands-on IC