QA Lead- Regulatory Affairs, SQR (Open)

About the role

Systems, Quality & Regulatory (SQR), a global function within Care Enablement ensuring Fresenius Medical Care’s products meet the highest standards of quality, safety, and regulatory compliance throughout the entire product lifecycle. The team supports market access, innovation, and patient safety by driving excellence across manufacturing and supply chain, overseeing post-market surveillance, and promoting continuous improvement and system harmonization.

What you'll do

• As Manager, Quality Management, you will build and lead the hosted Quality Management team based at our Global Business Services (GBS) campus in Bangalore
• Be accountable for quality deliverables across Fresenius Medical Care’s global product portfolio as a full member of the global SQR team
• Build, lead and develop a high-performing Quality Management team – recruitment, onboarding, coaching, performance management and succession planning
• Hold end-to-end accountability for quality deliverables as an integral part of the global and regional Quality teams: controlled document management, supplier quality
• Own document control processes – authoring, review, approval and maintenance of SOPs, work instructions and controlled records – ensuring compliance with ISO 13485

What you need

• Regulatory affairs
• ISO 9001
• Internal audit
• SAP
• Power BI
• Performance management

Good to have

• Six Sigma
• Lean
• Talent management
• SOP writing
• Complaint handling