Quality System Specialist

Carpplix seeks a Quality System Specialist join this exciting start-up that is changing the

face of mobile health. In this role, you will be responsible for the hands-on, day-to-day

support of Careplix’s Quality Management System (QMS) to ensure compliance to company

procedures, FDA QSR, ISO 13485, EUMDR and other regulatory standards. Main duties

include the processing and maintenance of all QMS-related documents and records, related

to product design history files, CAPAs/NCs, training, external standards, suppliers, audits,

and calibration. Additional responsibilities include supporting internal and external audits

and quality improvement initiatives. This role requires the candidate to be based out of our

office in Kolkata, India.

Responsibilities: 

 Support the Quality Systems Manager in the management of Careplix’s 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 new 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

Requirements:

 Bachelor’s degree in Science or Engineering

 3+ years of 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