ISO Regulatory Compliance Associate
3 - 5 yrs
₹4L - ₹12L / yr
Bengaluru (Bangalore)
Skills
Regulatory affairs
data privacy
ISO/IEC 27001:2005
ISO 27001
soc2
Quality audit
FDA
samd
eu
Job Title: QA Associate
Job Description:
- Responsible for Implementing, controlling and monitoring quality management system documentation (ISO 27001) and data privacy (SOC2).
- Coordinate improvement in the system through output from audit, management review, and responsible to close NC’s during audits.
- Knowledge of SAMD (Software as Medical Device) SaaS product, processes and procedures.
3-5 years of relevant experience in Medical Devices Industry.
Area of Expertise:
- To generate, implement and maintain internal quality procedures and systems to comply with ISO 27001, SOC2 standards
- Maintaining and updating various documents like internal docs log, external log, , Obsolete docs log, DCN, ECN, CAPA, SQA/IQA log, product complaint, equipment log
- Maintaining Engineering documents like part specs, Bill of materials, Drawings, Design review documents etc
- Co-ordinate and conduct periodic internal audits of various functional groups of an organization and drive compliance to QMS.
- Manage all documentation related to internal and external audit.
- Manage all the documents related to supplier qualification and coordinate Supplier’s audit and maintain the supplier file.
- Experience in Handling of CAPA (Corrective & Preventive Actions) & Product Complaints
- Co-ordination of Management Review Meetings & its action items implementation
Experience Required:
- 3-5 years of relevant experience in Medical Devices Industry.
- Educational Qualification – Diploma/Engineering graduate, preferably Computer Science or related.
- Ability to read and understand standard requirements independently.
- Good teamwork, communication and interpersonal skills. A demonstrated commitment to company values
- Good understanding of design control, and post marketing processes
- Knowledge of FDA / EU / Indian & other national regulations is an added advantage.
- Working knowledge of an e-QMS is an added advantage.
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About Synapsica Technologies Pvt Ltd
Founded :
2017
Type :
Services
Size
Stage :
Raised funding
About
Synapsica is a HealthTech and Teleradiology firm founded by alums from AIIMS Delhi, IIT - KGP & IIM - A with a vision to increase accessibility of diagnostic services to every corner of world. We are developing Artificial Intelligence for Radiodiagnosis to aid radiologists by reducing errors, improving efficiency and automating any monotonous work. Presently, our radiologist and tech panel has some of the best talent from top institutes in the country.
We use NLP, Computer Vision & Deep Learning based software products to assist diagnosis in X-Ray, CT and MRI scans. Our Machine Learning automation allows for workflow management at Diagnostic Centers bringing efficiency to the entire process of stakeholders coordination, disease interpretation & report generation.
Through our efforts we hope to bring accountability, standardization, efficiency and hence better patient care to the medical field.
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Tech stack
Kubernetes
Amazon Web Services (AWS)
Docker
PythonFirebase
MongoDB
React.js
NodeJS (Node.js)
Machine Learning (ML)Company video
Candid answers by the company
What is Synapsica Healthcare?
How do you define the company’s culture?
Two things techies don’t like about the company?
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Shubham Vishwakarma
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