Senior Design Quality Engineer
Core
Ensuring compliance with safety standards and global regulatory requirements for medical device and biologics products through quality engineering and process development.
Role type
Senior Design Quality Engineer
Builds
Medical devices and biologics/therapeutics products
Domain
Medical Device / Biologics / Regulatory Compliance
Required skills
Design History File (DHF) management, Risk Management File (RMF) management, FDA regulations (21 CFR Part 820), ISO standards (13485, 14971), IEC standards (60601, 62304), NPD lifecycle management, Complaint investigations, Design change controls, Project management
Preferred skills
Product development experience with medical devices, Sustaining-life cycle management
Technologies
FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 60601, IEC 62304, EU MDD, EU MDR
Responsibilities
Lead audit ready status efforts for assigned areas, Take lead role in NCR/CAPA activities, Support risk management activities for product and post market surveillance, Work with R&D to develop Product Design Requirements and Test Methods, Defend/support product design history file (DHF) in internal and external audits
Seniority
Senior, hands-on IC