Overview
Quality Management System; QMS Specialist – Medical Devices Jobs in Bengaluru, India at NexorTest Technologies
Position: Quality Management System (QMS) Specialist – Medical Devices
Location: Bengaluru
Location:
Bangalore (On-site)
Employment Type:
Full-time
Industry: Medical Devices
CTC: INR 5 LPA-6 LPA
Experience required: 5- 7 Years
About the Role
We are seeking an experienced QMS Specialist to lead the establishment, implementation, and maintenance of a compliant Quality Management System for a medical devices organization. This role is critical in ensuring alignment with global regulatory standards and supporting product lifecycle compliance.
Key Responsibilities
Lead the development and implementation of the QMS in compliance with:
ISO 13485
FDA 21 CFR Part 820 (QMSR)
EU MDR (as applicable)
Establish and maintain key quality system processes, including:
Document Control
CAPA (Corrective and Preventive Actions)
Change Control
Risk Management (ISO 14971)
Supplier Quality Management
Complaint Handling & Post-Market Surveillance
Prepare the organization for regulatory inspections and audits (FDA, Notified Bodies, internal audits)
Develop and maintain Quality Manuals, SOPs, and Work Instructions
Support product development teams with Design Controls and Design History Files (DHF)
Ensure proper training programs are developed and implemented across teams
Monitor QMS effectiveness through KPIs, internal audits, and management reviews
Act as a quality representative during regulatory submissions and inspections
Qualifications
Bachelor’s degree in Engineering, Life Sciences, or related field (Master’s preferred)
5–10 years of experience in medical devices quality/regulatory roles
Strong knowledge of:
ISO 13485
FDA QSR (21 CFR Part 820)
EU MDR / CE Marking processes
Hands-on experience in building or significantly improving a QMS from scratch
Experience with audit readiness and regulatory inspections
Certification such as Certified Quality Auditor (CQA) or Lead Auditor ISO 13485 is a plus
Key Skills
Strong understanding of regulatory compliance frameworks
Excellent documentation and technical writing skills
Detail-oriented with strong analytical capabilities
Effective cross-functional collaboration
Problem-solving and risk-based thinking
Preferred Experience
Experience in startup or early-stage medical device companies
Exposure to software as a medical device (SaMD) (if applicable)
Familiarity with electronic QMS (eQMS) tools
Thank you
Nexor Test Technologies
Title: Quality Management System; QMS Specialist – Medical Devices
Company: NexorTest Technologies
Location: Bengaluru, India
Category:
