Senior Quality Engineer
Core
Senior Quality Engineer supporting new product development and maintenance for medical devices, ensuring compliance with design control and regulatory requirements.
Role type
Senior IC Quality Engineer (Medical Devices)
Builds
Medical device products and processes
Domain
Medical Technology / Regulatory Compliance
Required skills
Design Control, Risk Management, Process Validation, CAPA, Root Cause Analysis, Statistical Sampling, Supplier Qualification, Post Market Surveillance, Regulatory Standards (21-CFR-820, ISO 13485, MDD, MDR, ISO 14971, ISO 10993), Change Control
Preferred skills
Six Sigma, ASQ Certification
Technologies
Quality Engineering Tools, Statistical Software
Responsibilities
Develop technical solutions to complex quality problems, modify methodologies for continuous improvement, support quality system audits, perform root cause investigations for deviations, validate test methods, liaise with manufacturing plants, provide functional support to cross-functional teams, advise on regulations and standards.
Seniority
Senior, hands-on IC