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ISO Regulatory Compliance Associate
ISO Regulatory Compliance Associate

ISO Regulatory Compliance Associate at Synapsica Technologies Pvt Ltd · Bengaluru (Bangalore) · 3 - 5 years · ₹4L - ₹12L / yr · Raised funding · Posted 14 Aug 2021

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ISO Regulatory Compliance Associate

Human Resources's profile picture
Posted by Human Resources
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:

  1. Responsible for Implementing, controlling and monitoring quality management system documentation (ISO 27001) and data privacy (SOC2).
  2. Coordinate improvement in the system through output from audit, management review, and responsible to close NC’s during audits.
  3. 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

skill iconKubernetes
skill iconAmazon Web Services (AWS)
skill iconDocker
skill iconPython
Firebase
skill iconMongoDB
skill iconReact.js
skill iconNodeJS (Node.js)
skill iconMachine Learning (ML)

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Shilpi Shrivastava
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Bengaluru (Bangalore)
1 - 3 yrs
₹6L - ₹10L / yr
Manual testing
Test Planning
Artificial Intelligence (AI)

Job Description:

As a QA Associate at Binocs, you will play a pivotal role in ensuring the highest quality standards for our software products. With a direct reporting line to the QA Lead, you will be involved in designing, implementing, and executing test plans to identify software issues. This role is ideal for someone with a strong technical background in engineering, experience in fintech or finance software companies, and a passion for quality assurance and detail-oriented testing.


Key Responsibilities:

  • Test Plan Development: Create comprehensive and well-structured test plans and test cases based on product specifications.
  • Quality Assurance: Execute test cases (manual or automated) and analyze results to ensure software quality.
  • Issue Documentation: Document and track bugs, as well as collaborate with the development team to ensure timely resolution.
  • Process Improvement: Identify, recommend, and implement improvements in testing processes to enhance efficiency and quality.
  • Software Validation: Validate that product features meet requirement specifications and are free of defects.
  • Cross-functional Collaboration: Work closely with the product management and development teams to understand product vision and deliver software that aligns with customer and market needs.


Qualifications:

  • Bachelor’s degree in Engineering, Computer Science, or related field.
  • 2+ years of experience in quality assurance, preferably within fintech or finance software companies.
  • Familiarity with software QA methodologies, tools, and processes.
  • Experience in writing clear, concise, and comprehensive test plans and test cases.
  • Hands-on experience with both white box and black box testing.
  • Strong knowledge of software QA metrics, including bug tracking and reporting tools.
  • Excellent analytical skills and attention to detail.
  • Effective communication skills and the ability to work in a fast-paced environment.


Benefits:

Joining Binocs means being part of a passionate team dedicated to transforming the loan management landscape. We offer a dynamic, innovative environment where your work directly contributes to our vision of efficient, transparent, and data-driven loan management. Our competitive compensation package, including equity, reflects our commitment to attracting and retaining top talent.


About Us:

Binocs.co empowers institutional lenders with next-generation loan management software, streamlining the entire loan lifecycle and facilitating seamless interaction among stakeholders.

Team: Binocs.co is led by a passionate team with extensive experience in financial technology, lending, AI, and software development.

Investors: Our journey is backed by renowned investors who share our vision for transforming the loan management landscape: Beenext, Arkam Ventures, Accel, Saison Capital, Blume Ventures, Premji Invest, and Better Capital.

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