ZEISS Group is seeking a Quality Manager for their Bengaluru office, focused on maintaining compliance with Quality Management Systems (QMS) and regulatory standards for healthcare products. The ideal candidate should have extensive experience in quality management, particularly in ISO 13485, and a robust understanding of medical device regulations
Job Summary
This individual will work with the Head of Quality to make sure that the QMS (Quality Management System) is maintained with the required processes and templates, coordinated, and synchronized with the Global harmonized QMS.
Support development of SOPs / Work Instructions / Working documents for product development and support processes.
Guide Project / Product development team to follow QMS processes along with Quality Specialist(s).
Matching Summary
Match Score: 85
ZEISS Group is seeking a Quality Manager for their Bengaluru office, focused on maintaining compliance with Quality Management Systems (QMS) and regulatory standards for healthcare products. The ideal candidate should have extensive experience in quality management, particularly in ISO 13485, and a robust understanding of medical device regulations.
Skills & Requirements
Must-have
Quality Management System
ISO 13485
MDSAP
regulatory requirements
product development processes
Risk Management ISO 14971
Nice-to-have
continuous improvement initiatives
distributed team members
Agile development methods
Information Security Concepts
Data Privacy Concepts
Key Requirements
10-15 years of experience
6-7 years in Quality Management
6-7 years with SW development teams
Strong knowledge of EU MDR, US FDA, ANVISA
Internal Auditor / Lead Auditor certified for ISO 13485:2016
Experience conducting Internal Audits and facing external audits