Responsibilities:

- Support the Quality Systems Manager in the management of Careplixs QMS.
- Maintain the efficiency of Careplix document control process and compliance to Careplix and regulatory standards.
- Manage creation, revision, and obsolescence of SOPs, Work Instructions (WRKs), and forms in accordance with document control procedures and assist Careplix team.
- Members with processing of urgent documents, reminders, and status updates, as needed.
- Assist in compiling and organizing design inputs, risk management files,Verification/validation reports, and other technical documentation.
- Support current product development teams in maintaining robust design controls by verifying that Design History Files (DHFs) accurately reference the current document numbers, revisions and associated Quality Records.
- Manage training records and assignments for quality-controlled procedures, including coordinating document revisions, running overdue training reports, sending overdue reminders, administering quizzes, facilitating password resets, and maintaining records per retention policies.
- Assist CAPA and NC owners with ensuring completeness of records.
- Prepare monthly meeting metrics, maintain logs, and send reminders for required activities (i.e. due dates and effectiveness checks)
- Manage and maintain the Approved Supplier List (ASL), ensure documentation is up-to-date for all suppliers, and coordinate activities related to supplier qualification, periodic re-evaluation, and audits in accordance with the Supplier Control procedures.
- Assist in the preparation of documents/metrics for Management Review meetings and maintain meeting records
- Support internal, supplier,



and regulatory audits by ensuring documentation readiness, process adherence, compiling required deliverables, and tracking post-audit findings through to timely corrective action and closure.
- Maintain comprehensive calibration logs, coordinate timely calibration activities with internal teams or external metrology vendors, ensure accurate documentation of all measuring and monitoring equipment, and proactively verify compliance with established calibration schedules and quality standards.
- Support the integration of new requirements into the Quality Management System and applicable procedures to ensure ongoing compliance.
- Coordinate, manage, and lead programs related to quality improvement or business objectives as assigned by Quality System Manager and assist other functional areas,as needed. KeySkills -
- Document control, QMS management, supplier management, and/or training administration function in the medical device or other regulated industry
- Working knowledge of FDA QSR (21 CFR 820), ISO 13485, EUMDR and applicable standards (ISO 14971, IEC 62366, etc.).
- Knowledgeable of Good Documentation Practices to perform and execute job responsibilities with a high level of accuracy.
- Demonstrated ability to communicate effectively with internal and external customers and develop expertise to provide improved assistance.
- Have good communication skills, both written and verbal. Strong editorial and technical writing skills a plus.
- Excellent organisational skills along with strong attention to detail ability to work both independently and collaboratively with small, cross-functional teams. Qualification
- At least Bachelors degree in Science or Engineering

Location:
Kolkata

📌 Quality Analyst (Kolkata)
🏢 Carenow Healthcare
📍 Kolkata