Wipro is inviting applications for the position of CAPA Coordinator at its Kolkata location. This opportunity is ideal for quality professionals with strong exposure to medical device regulations, CAPA systems, and audit readiness. Candidates with experience in Root Cause Analysis (RCA) and global regulatory standards such as ISO 13485 and 21 CFR 820 will be well-suited for this role.
This role plays a critical part in maintaining compliance, driving continuous improvement, and ensuring that corrective and preventive actions meet stringent quality standards in the medical devices domain.
🧩 Key Responsibilities
- Perform and review Root Cause Analysis (RCA) using tools such as 5-Why Analysis, Fishbone, and related methodologies
- Act as CAPA Audit Approver, ensuring CAPAs comply with internal quality standards before progression
- Review, assess, and approve CAPA effectiveness and closure documentation
- Support internal and external quality audits; prior auditor experience is an advantage
- Ensure compliance with applicable medical device regulations and standards
- Collaborate with cross-functional teams to drive quality improvements and regulatory compliance
🎓 Qualifications & Experience
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biomedical Engineering, or related discipline
- Proven experience in CAPA management within medical devices or regulated industries
- Strong understanding of the following regulations and standards:
- ISO 13485
- 21 CFR 820 (FDA QSR)
- EU Medical Device Directive (93/42/EEC)
- EU Medical Device Regulation (EU MDR 2017/745)
- Canadian Medical Devices Regulations (SOR/98-282)
- Experience as an internal or external auditor is preferred
- Strong documentation, analytical, and communication skills
💼 Salary & Benefits
- Estimated Salary Range: ₹6,00,000 – ₹10,00,000 per annum (INR), depending on experience and expertise
- Opportunity to work with a globally recognized organization
- Exposure to international regulatory frameworks
- Professional growth in medical device quality and compliance
- Structured quality systems and audit-driven work environment
📍 Job Location
Kolkata, West Bengal, India
📩 How to Apply
Interested and eligible candidates are requested to share their updated resume via email:
📧 Email: sarita.biswas@wipro.com
Subject Line (Recommended): Application for CAPA Coordinator – Kolkata
