Senior Design Quality Engineer
Core
Senior Design Quality Engineer ensuring compliance and driving continuous improvement for laser consoles and fibers in the medical device industry.
Role type
Senior Design Quality Assurance Engineer
Builds
Laser Therapies portfolio (laser consoles and fibers)
Domain
Medical Devices / Laser Therapies
Required skills
Design Quality Assurance, Risk Management, Design Controls, Verification and Validation, Regulatory Compliance (ISO 13485, ISO 14971, FDA QMSR, EU MDR), Product Lifecycle Management, Technical Analysis, Problem Solving
Preferred skills
Certified Quality Engineer (CQE)
Technologies
ISO 13485, ISO 14971, FDA QMSR, EU MDR
Responsibilities
Partner with R&D, Regulatory, Clinical, and Manufacturing teams to ensure product quality; Serve as SME for Quality Management System and regulatory compliance; Provide independent quality reviews of design documentation and risk assessments; Investigate complex quality challenges and drive risk-based decisions; Provide Design Quality guidance to product development and sustaining engineering; Maintain and improve design control and risk management processes; Coordinate quality activities across multidisciplinary teams.
Seniority
Senior, hands-on IC