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
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- Experience with design controls, ISO 14971 risk management, and CAPA leadership
- Prior team management or mentoring experience preferred
Education:B.E./B.Tech or M.Sc. in Biomedical Engineering, Life Sciences, Biotechnology, or a related field
Preferred certifications:RAC, ISO 13485 Lead Auditor, CQE/CQM
experience
10show more 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./B.Tech or M.Sc. in Biomedical Engineering, Life Sciences, Biotechnology, or a related field
Preferred certifications:RAC, ISO 13485 Lead Auditor, CQE/CQM
experience
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