Senior Executive - Quality Assurance
On-site · Hyderabad, Telangana, India
Job Summary
Senior Executive – Quality Assurance leading validation activities for equipment, processes, software, and sterilization in compliance with ISO 13485, EU MDR, and applicable regulatory standards; plan and manage calibration activities with audit-ready documentation; oversee label management via NiceLabel; support quality systems including documentation control, deviations, change management, and internal audits; actively participate in CAPA processes from root cause analysis to implementation and tracking in the B.TraQS system; join Oyster Medisafe Pvt. Ltd. in Hyderabad as part of the B. Braun group, bringing 5–7 years of quality management experience in medical devices and a deep understanding of regulatory requirements.
Required Qualifications
- 5–7 years of hands-on quality management experience in medical devices or plastics
- strong knowledge of injection molding and extrusion processes
- global regulatory requirements including ISO 13485, EU MDR 2017/745, CE marking, and Indian Medical Device Rules
- documentation, system-handling, and audit management skills
- CAPA processes from root cause analysis to implementation and tracking
- clear communication and cross-functional collaboration
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