Overview
Junior Quality Specialist Jobs in Navi Mumbai, Maharashtra, India at Stemtech Medical Devices
Title: Junior Quality Specialist
Company: Stemtech Medical Devices
Location: Navi Mumbai, Maharashtra, India
Junior Quality Specialist
Reporting to: Head of Quality
Industry: Medical Devices | Oncology Supportive Care
Location: Navi Mumbai, India
ABOUT STEMTECH
Stemtech Medical Devices is India's leading oncology supportive care company. Our flagship product, the EVA Scalp Cooling System, helps cancer patients reduce chemotherapy-induced hair loss preserving confidence and quality of life during treatment.
We are the first company in Asia to design and manufacture a scalp cooling system, built entirely in house from R&D to manufacturing. EVA is FDA-cleared and CDSCO-registered, and is currently deployed across 80+ installations in India, with active expansion underway.
Our work has been recognized on a national stage — featured on Shark Tank India and backed by funding from the Department of Science and Technology (DST), Government of India — a reflection of the impact and innovation behind what we're building.
As a fast-growing medical device company at the intersection of healthcare and engineering, we're looking for passionate young professionals who want to build their careers in Quality Assurance, Regulatory Compliance, and Medical Device Manufacturing — and be part of a team solving a real problem for cancer patients, from India to the world.
THE ROLE
This is an excellent opportunity for fresh graduates who want to develop expertise in quality systems and regulated medical device development.
As a Junior Quality Specialist, you will support quality management activities, documentation control, supplier quality, inspections, audits, and continuous improvement initiatives while learning industry standards such as ISO 13485 and MDSAP.
KEY RESPONSIBILITIES
1. Quality Management System (QMS)
- Support maintenance of the ISO 13485 Quality Management System
- Assist in document control and record management activities
- Support change control, CAPA, NCR, and deviation management processes
2. Incoming & Production Quality
- Perform incoming inspection of purchased components and materials
- Support in-process and final product inspections
- Maintain inspection records and quality reports
3. Supplier Quality
- Assist in supplier qualification and evaluation activities
- Track supplier quality performance and corrective actions
- Support supplier documentation reviews
4. Audits & Compliance
- Assist during internal, customer, and certification audits
- Support compliance with ISO 13485, MDSAP, and regulatory requirements
- Help prepare quality metrics and audit documentation
5. Continuous Improvement
- Participate in root cause investigations and corrective actions
- Support process improvement projects
- Contribute to quality culture across the organization
IDEAL CANDIDATE PROFILE
Education
B.E./B.Tech in Biomedical Engineering, Mechanical Engineering, Electronics Engineering, Instrumentation Engineering, B Pharmacy or related fields
Freshers or candidates with up to 1 year of experience
Desired Skills
Basic understanding of quality systems and documentation
Good analytical and problem-solving skills
Proficiency in Microsoft Excel and MS Office
Strong communication and organizational skills
Attention to detail and willingness to learn
Preferred
Knowledge of ISO 13485, GMP, or medical device regulations
Internship/project experience in manufacturing or quality assurance
WHAT YOU WILL LEARN
Medical Device Quality Management Systems
ISO 13485 & MDSAP Compliance
Supplier Quality Management
Root Cause Analysis & CAPA
Audit Management
Regulatory Documentation
Freshers are strongly encouraged to apply.
