3+ QMS Jobs in Bangalore (Bengaluru) | QMS Job openings in Bangalore (Bengaluru)
Apply to 3+ QMS Jobs in Bangalore (Bengaluru) on CutShort.io. Explore the latest QMS Job opportunities across top companies like Google, Amazon & Adobe.
Job Title : Medical Device Engineer
Location : Bangalore / Pune
Experience : 5+ Years total, with at least 3 years in Medical Device Development, Sustenance, or DHF Remediation
Notice Period : Immediate to 1 week
Interview Process : L1-selected candidates will undergo a customer interview
Mandatory Skills : Medical Device Development/Sustenance/DHF Remediation, ISO 13485, IEC 60601, ISO 14971, FDA & EU MDR compliance, DHF documentation, Design FMEA, CTS/CTQ, QMS, PLM, Verification & Validation, Impact Assessment.
Key Skills & Knowledge :
- Strong understanding of ISO 13485, IEC 60601, and ISO 14971 standards
- Experience with FDA and EU MDR regulatory requirements
Responsibilities :
- Conduct gap assessments and create/update DHF documents, including user and product requirements, design FMEA, CTS/CTQ, and standards compliance reports
- Analyze and implement design changes, assess impact, and update documentation accordingly
- Identify gaps in verification and validation, ensuring clear traceability between requirements and verification documents
- Assess compliance with applicable standards and regulations
- Define CTS/CTQ parameters and actively participate in design reviews
- Follow QMS guidelines and manage changes through PLM.
C++Skills: C++, QT, UI, TCP/IP, HTTP/HTTPS, Networking Protocols
Branch: Computer Science (B.E/B.tech)
Location: Bangalore (Work from Office)
Experience- 1-5yrs
What you will do:
- Working closely with the external auditors to achieve common goals
- Conducting Enabling Service Audit (HR, Admin, IT) once in 6 months for the verification of ISMS & QMS Standards
- Performing ISMS and Internal Audit
- Being part of the external Audits (ISMS, QMS & CMMI)
- Managing of implementation of ISMS
Desired Candidate Profile
What you need to have:- Strong communication and team building skills with proficiency at grasping new technical concepts quickly and utilizing the same in a productive manner
- Experience in ISO27001, Internal Audits, CMMI
Follow Cutshort