QA Lead- Regulatory Affairs, SQR (Open)

Fresenius Medical CareHebbal, BangalorePosted a month ago

Manager
Hybrid
Full time
12 to 16 years

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About the role

Fresenius Medical Care’s SQR function supports quality, safety and regulatory compliance across its medical products and global operations. You will lead the Bangalore Quality Management team and oversee quality processes, compliance, data governance and global deliverables.

What you'll do

Build and develop the Bangalore Quality Management team
Own controlled document processes and maintain inspection-ready quality records
Oversee supplier quality, CAPA, non-conformance and complaint-handling activities
Govern quality data and track team performance and compliance metrics
Scale Bangalore quality capabilities and drive process standardisation and improvement
Represent the team in global quality forums and support audits and inspections

Skills

Must have

Quality management
Qms document control
Supplier quality management
Capa management
Non-conformance handling
Internal audits
Iso 13485
Iso 9001
Iso 14971
21 cfr parts 820/qmsr

Nice to have

Lean
Six sigma

Tools

Veeva vault qms
Trackwise
SAP
Power BI

Who it's for

Education: Bachelor's degree
Degree: life sciences, pharmacy, biomedical engineering, biotechnology engineering
Experience: 12 to 16 years
Languages: english
Domain: medical devices

About Fresenius Medical Care

Fresenius Medical Care has 35 open roles in Bangalore, at Fresenius Medical Care Global Business Services (GBS) Bangalore. See every Fresenius Medical Care role.