Quality Assurance Principal
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About the role
DeepHealth develops healthcare products subject to quality and regulatory requirements. The Quality Assurance Principal leads design and product lifecycle quality work, owns assigned QMS processes, and supports compliance and audits.
What you'll do
- Lead design quality for new products and design changes
- Own assigned QMS processes, including CAPA and complaint management
- Guide junior quality assurance colleagues in quality processes
- Support regulatory audits and monitor quality metrics
- Drive corrective and preventive actions to closure
Skills
Must have
- Quality management systems
- Design quality
- Design control
- Risk management
- Fda quality system regulations
- 21 cfr part 11
- 21 cfr part 820
- Capa
- Complaint management
Nice to have
- Fda-regulated industry
- Software as a medical device
- Eu mdr
- Iso 13485
- Iso 14971
- Iec 62304
- Clinical study requirements
- Regulatory audits
Who it's for
- Education
- Bachelor's degree
- Experience
- 8 to 10 years
- Domain
- healthtech medical devices
About DeepHealth
DeepHealth has 5 open roles in Bangalore, at Cignus Tower. See every DeepHealth role.
More at DeepHealth
Lead or staff · Remote · 10+ years
Lead or staff · Hybrid · 8 to 10 years
Senior · Hybrid
Manager · Hybrid · 10+ years
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