Quality Assurance Engineer
Core
Lead and support quality assurance activities for new product development and sustaining engineering programs in medical technology, ensuring compliance with internal systems and global regulatory requirements.
Role type
Senior IC Quality Assurance Engineer (Medical Devices)
Builds
Medical device products and integrated technologies
Domain
Medical technology / Orthopedics / Regulated manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk management (ISO 14971), Design controls, Internal/external audit execution, CAPA management, Root cause analysis, Regulatory compliance (ISO 13485, FDA, GMP), Technical writing, Manufacturing process knowledge (metrology, machining, sterilization)
Preferred skills
Six Sigma/Lean certification, PLM tools (SolidWorks, ePDM, Oracle R12, Agile PLM), Multilingual ability (Spanish, German, French)
Technologies
ISO 13485, ISO 14971, FDA regulations, GMP, Microsoft Office Suite, ePDM, Oracle R12, Agile PLM, SolidWorks
Responsibilities
Lead and manage Corrective and Preventive Actions (CAPA), Conduct internal audits across quality system processes, Develop and maintain DFMEA/UFMEA documentation, Review and approve design control documentation, Act as subject matter expert for design quality during audits, Investigate trends in product failures and complaints, Participate in design and manufacturing reviews
Seniority
Mid-level, hands-on IC