PCI - Direct Client - Quality Specialist
Category:
Software / QA / DBA
Company:
Professional Consulting, Inc
Email:
Description:
Role: Quality Specialist
Location: Philadelphia, PA (Onsite)
Term: Contract
Skills:
- B.E (Mechanical or Biomedical) with 6 to 8 years of experience in Quality in Medical Devices industry (Experience in SaMD would be preferred)
- Strong understanding of ISO 13485, MDSAP, EU MDR 2017/745, US FDA 21 CFR Part 820 and applicable regulatory requirements.
- Excellent level of knowledge and working experience of Quality domain and its related activities.
- Support in QMS integration of different sites to create a harmonised QMS.
- Remediation support for Design (DHF), Design content, Risk files, and Cybersecurity.
- Support on ongoing design projects
- Support in LMS implementation
- Support in data migration validation
- Support in document migration validation
- Excellent knowledge about regulatory standards (ISO 13485, ISO 14971, IEC 62304, IEC 62366 et