Quality Engineer - II
Core
Execute post-market surveillance activities, lead complaint investigations, and manage regulatory submissions for interventional cardiology devices.
Role type
Quality Engineer II (Medical Devices)
Builds
Post-market quality operations and regulatory compliance for implantable medical devices
Domain
Healthcare / Medical Devices / Regulatory Affairs
Deliverable
dashboards & analysis
Required skills
complaint investigation, complaint trending, risk assessment, regulatory query response, PSUR management, cross-functional collaboration, product hazard analysis review, process improvement
Preferred skills
cardiovascular/implant procedure knowledge, highly regulated industry experience, product development cycle knowledge
Technologies
None explicitly stated
Responsibilities
Lead complaint investigations and trend analysis; Prepare regulatory responses for product registrations; Partner on risk analysis for new products; Maintain periodic safety update reports (PSUR); Develop solutions for unique quality issues; Prioritize and escalate quality issues
Seniority
Mid-level, hands-on IC
