Posted:8 hours ago|
Platform:
Work from Office
Full Time
Strong knowledge of FDA QSR, ISO 13485, EUMDR & regulatory norms. Manage QMS docs, DHFs, CAPAs, audits, suppliers, training & calibration. Support audits, product dev, quality improvements & regulatory compliance. Excellent doc & comm skills needed.QMS Management: Oversee and manage essential Quality Management System documentation, including Design History Files (DHFs), CAPAs (Corrective and Preventive Actions), and change controls. Regulatory Compliance: Ensure strict adherence to FDA QSR (21 CFR Part 820), ISO 13485, EUMDR (EU Medical Device Regulation), and other relevant regulatory norms. Audit Support: Actively support internal and external audits (e.g., FDA, Notified Body), ensuring readiness and effective follow-up. Supplier Quality: Manage supplier qualification, monitoring, and quality agreements to ensure materials and services meet specifications. Training & Calibration: Coordinate and maintain training records and calibration programs to ensure compliance and operational effectiveness. Quality Improvement: Collaborate on product development initiatives and drive continuous quality improvements across the organization.
Careplix
Upload Resume
Drag or click to upload
Your data is secure with us, protected by advanced encryption.
Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.
We have sent an OTP to your contact. Please enter it below to verify.
Instantly access job listings, apply easily, and track applications.
Kolkata
2.5 - 5.0 Lacs P.A.
3.0 - 4.8 Lacs P.A.
Gurugram
4.0 - 9.0 Lacs P.A.
Thane
Experience: Not specified
3.0 - 4.0 Lacs P.A.
Bengaluru
Experience: Not specified
2.16 - 4.2 Lacs P.A.
8.0 - 12.0 Lacs P.A.
2.0 - 5.0 Lacs P.A.
Mumbai, Ambarnath
Experience: Not specified
2.0 - 5.0 Lacs P.A.
Navi Mumbai
3.0 - 5.0 Lacs P.A.
Thiruvananthapuram
Experience: Not specified
7.8 - 7.8 Lacs P.A.
