Qa Professional

Danaher UK

Bangalore, India
Not specified; eligible for bonus/incentive pyy; c...
5-7 years qa experience in medical devices
Expertise in iso 14971 risk management
Knowledge of fda 21 cfr 820 and iso 13485
The role involves leading quality assurance activities for design and development projects including outsourced design to ensure compliance with global regulations

Job Summary

  • The role involves leading quality assurance activities for design and development projects including outsourced design to ensure compliance with global regulations.
  • Candidates will advise on critical design control elements such as risk management, usability engineering, and requirement traceability within the healthcare sector.
  • The position offers a collaborative environment at Radiometer where employees can drive continuous improvement using the Danaher Business System.

Matching Summary

The role involves leading quality assurance activities for design and development projects including outsourced design to ensure compliance with global regulations.

Salary

Not specified; Eligible for bonus/incentive pay; Comprehensive benefits package including paid time off and insurance

Skills & Requirements

Must-have

  • 5-7 years QA experience in medical devices
  • Expertise in ISO 14971 risk management
  • Knowledge of FDA 21 CFR 820 and ISO 13485
  • Experience with IEC 62304 software lifecycle
  • Design control process leadership

Nice-to-have

  • Mentorship of junior team members
  • Understanding of immunoassay principles
  • Familiarity with cybersecurity standards
  • Continuous improvement mindset
  • Global regulatory market knowledge

Key Requirements

  • B.Tech/M.Tech/BE degree or equivalent university education
  • 5-7 years of Quality Assurance experience
  • Hands-on experience with ISO 14971 and IEC 62304
  • Proven expertise in regulated environments (FDA, MDR, IVDR)

Work Rights

Not specified

Tailored Resume

Cover Letter