ISO Regulatory Compliance Associate

at Synapsica Technologies Pvt Ltd

ISO Regulatory Compliance Associate

Synapsica Technologies Pvt Ltd

Company

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ISO Regulatory Compliance Associate

at Synapsica Technologies Pvt Ltd

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

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.

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.

Kubernetes

Amazon Web Services (AWS)

Docker

Python

Firebase

MongoDB

React.js

NodeJS (Node.js)

Machine Learning (ML)

Company video

Synapsica Technologies Pvt Ltd's video section

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?

What can get you fired?

What is the compensation philosophy?

Why join Synapsica Healthcare?

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Building pixel-perfect, robust and, accessible user interfaces on the web
Not just building new features, but also building reusable components and libraries which help in delivering faster.
Taking responsibility of quality and making things easy and predictable by automating these processes
Exploring and designing dynamic and compelling consumer experiences.
Working closely with designers to implement versatile front-end solutions while embracing emerging standards and pushing the limits of what a browser can do.
Actively participating in design and code reviews to build robust applications and prototypes.
Interacting with other team members to passionately collaborate in building a rich and innovative user experience
Analyzing system function and performance requirements to support design concepts.
Mentoring new members, interviewing and helping in building high performance teams.

What you need to have:

B.E/ B.Tech or M.S in Computer Science or related technical field
3+ years of experience and must be hands-on with coding.
Ability to work with complex business flows
Excellent problem-solving, coupled with strong communication skills, and a sense of ownership and drive.
Experience building pixel-perfect, robust and, accessible user interfaces on the web
Experience in Single Page Application architecture
Proficient in at least one JavaScript framework like Angular, React or equivalent
Experience with CSS3 and Less/ Sass (ability to write mixins, partials, functions, etc) and usage in large scale applications
Experience in web analytics, accessibility, standards, and SEO techniques
Expertise in front-end design and JavaScript libraries such as AngularJS, ReactJS and jQuery.
Passion for building a rich and innovative user experience
Strong computer science fundamentals in design, data structures, and problem solving

Product Manager

at numberz

4 recruiters

Posted by Deeksha Saxena

Bengaluru (Bangalore)

4 - 7 yrs

₹20L - ₹24L / yr

Product Management

Product Strategy

Agile/Scrum

We are looking for a seasoned tech savvy Product Manager who is passionate about solving complex problems with in the B2B enterprise space. You will be part of a close-knit motivated team of rock stars both on the engineering and the Go to Market side. Key Responsibilities: • Build & maintain a dynamic product plan adapting to customer & market needs • Outside in focus with deep insights about customer workflow to convert pain points into simple, effortless & delightful experiences • Ruthless focus on what’s critical to create active, valuable and engaging experience for both new and existing users based on usage analytics & other relevant metrics • Ability to stack rank stories with creative balance of customer impact and effective use of engineering resources (biggest bang for the buck) • Build consensus across stakeholders – Marketing, Sales, Engineering and customers with clearly articulating the product decisions and choices Required Qualification • Proven track record with 3-5 years as Product Manager for B2B SaaS based product and ownership from concept to launch preferably in US market besides India • Comfortable conducting customer interviews remotely and in person and deep empathy with customer workflows & pain points • Proven experience of taking decisions based on validated learning combining qualitative and quantitative data from large customer usage & relevant data sets • Working knowledge of lean methodology, agile & iterative development • Ability to create detailed UX wireframes (Experience Design experience is a big plus)

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