, enabling radiologists to perform ultrasound scans remotely using a 7-DOF robotic arm, haptic feedback, pressure-controlled mechanisms, collision detection, and advanced communication systems .
As TORUS prepares for regulated deployment, the
Quality & Regulatory
team is critical for ensuring
patient safety
,
standards compliance
, and
regulatory approvals
.
Role Summary
The Quality & Regulatory Engineer will support all activities related to
quality management
,
risk management
,
regulatory documentation
, and
product compliance
for the TORUS robotic ultrasound system.
This role is suitable for
fresh graduates (including B.Pharm)
who want to build a career in
medical device QARA
.
Key Responsibilities1. Quality Management System (QMS)
Assist in implementing and maintaining QMS aligned with
ISO 13485
.
Prepare and maintain SOPs, Work Instructions, and controlled documents.
Support internal audits and readiness for certification audits.
2. Regulatory Affairs
Support documentation
Prepare regulatory submission files
Device description
Safety & performance data
Risk assessments
Clinical evaluation documents
Track and interpret new regulatory requirements.
3. Risk & Safety Documentation
Assist in building the
Risk Management File
as per
ISO 14971
.
Document safety features of TORUS including:
HIPAA-compliant data handling
Software Quality & Documentation
4. Product Testing & Verification
Support test planning and execution for:
Mechanical safety tests
Electrical safety basics (IEC 60601-1 exposure)
Software usability tests (IEC 62366 guidelines)
Document verification & validation (V&V) results.
Coordinate with engineering teams during prototype and pilot testing.
5. Documentation & Compliance Support
Maintain:
DHF (Design History File)
DMR (Device Master Record)
Technical File for regulatory submissions
CAPA, NCR, deviation reports
Ensure proper traceability from
user requirements ? design ? testing ? release
.
6. Supplier & Manufacturing Quality
Support vendor qualification and evaluation.
Inspect critical incoming components such as:
Robotic arm links
Gantry parts
Sensors, actuators, pressure modules
Assist in establishing IQ/OQ/PQ for production setup.
Required Qualifications
B.Pharmacy / M.Pharmacy
B.Tech / M.Tech
(Biomedical, Mechanical, Electronics, Robotics)
B.Sc / M.Sc Life Sciences
Skills & CompetenciesTechnical Skills
Basic understanding of quality systems or regulatory affairs.
Knowledge of documentation practices (GMP/GLP/QMS).
Familiarity with engineering or biomedical terminology (trainable).
Soft Skills
Strong attention to detail.
Excellent documentation and communication skills.
Ability to learn complex systems quickly.
Comfortable working in fast-paced R&D environments.
Preferred (But Not Mandatory)
Awareness of ISO 13485, ISO 14971
Prior internship in pharma/device QA/QC/RA
Understanding of medical device classification (CDSCO/CE)
Exposure to risk analysis tools (FMEA, HARA)
Why Join Plebc Innovations?
Work on a
ground-breaking medical robotic device
that solves a real healthcare access problem.
Learn directly from interdisciplinary experts in
robotics, medical devices, clinical workflows, and compliance
.
Grow into senior QARA roles as TORUS progresses toward
clinical studies and commercialization
.
Be part of a mission-driven team improving diagnostic access across India.
Job Type: Full-time
Pay: ?200,000.00 - ?360,000.00 per year
Work Location: In person
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