Engineer, Post Market Quality
Core
Provide quality engineering leadership and support for post-market quality, quality assurance, and quality control activities to ensure compliance and drive continuous improvement.
Role type
Post-Market Quality Engineer
Builds
Quality systems effectiveness and regulatory compliance for orthopedic medical devices
Domain
Medical Devices / Orthopedics
Deliverable
client delivery
Required skills
Root cause analysis, Risk management, Statistical analysis, CAPA management, Audit support, Regulatory compliance knowledge
Preferred skills
FDA/MoH/TUV regulatory experience, Human Factors considerations, Product field action management
Technologies
None stated
Responsibilities
Investigate and resolve product and process quality issues, Monitor and analyze quality metrics and KPIs, Support complaint investigations and product field actions, Participate in internal and external audits, Assist with quality containment activities
Seniority
Individual Contributor