Senior Quality Assurance Analyst (distributor & Wholesaler Quality)

Dexcom Inc

India
Iso 13485 knowledge
Who gdp compliance
Cdsco mdr 2017 expertise
This role is responsible for the overall quality and compliance of Dexcom products within India's healthcare landscape

Job Summary

  • This role is responsible for the overall quality and compliance of Dexcom products within India's healthcare landscape.
  • The position requires managing distributor and wholesaler quality agreements globally while ensuring adherence to local regulations.
  • Candidates will oversee regulatory inspections, audit resolution, and coordinate recall processes to safeguard patient safety.

Matching Summary

This role is responsible for the overall quality and compliance of Dexcom products within India's healthcare landscape.

Skills & Requirements

Must-have

  • ISO 13485 knowledge
  • WHO GDP compliance
  • CDSCO MDR 2017 expertise
  • QMS system implementation
  • Distributor quality audits
  • Temperature excursion investigations

Nice-to-have

  • Root cause analysis skills
  • Global stakeholder influence
  • Continuous improvement mindset
  • Fast-paced environment adaptability

Key Requirements

  • Bachelor's degree required
  • 5-8 years related experience
  • Knowledge of Indian Medical Device Rules (MDR 2017)

Work Rights

Not specified

Tailored Resume

Cover Letter