QA RA Manager
Job Location:
Monthly Salary:
Posted on:
9 days ago
Posted on:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
Hiring for QA RA Manager with mininum 5 years of experience
Required Attributes
5 years in QA/RA within medical devices or IVD
- Hands-on CDSCO submissions experience (Class B & C devices MDR 2017)
- Strong ISO 13485 QMS ownership and internal audit experience
- Familiarity with EU IVDR (Technical Files PER Notified Body liaison) and/or WHO Prequalification is a strong plus
- Experience with design controls ISO 14971 risk management and CAPA leadership
- Prior team management or mentoring experience preferred
Education:B.E./ Biomedical Engineering Life Sciences Biotechnology or a related field
- Strong ISO 13485 QMS ownership and internal audit experience
- Familiarity with EU IVDR (Technical Files PER Notified Body liaison) and/or WHO Prequalification is a strong plus
- Experience with design controls ISO 14971 risk management and CAPA leadership
- Prior team management or mentoring experience preferred
Education:B.E./ Biomedical Engineering Life Sciences Biotechnology or a related field
Preferred certifications:RAC ISO 13485 Lead Auditor CQE/CQM
