11+ FDA Jobs in Pune | FDA Job openings in Pune

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.

About Us :
Merito is a curated talent platform that helps growth companies to identify and hire quality talent faster. Setup by team of IIM Ahmedabad and HEC Paris alumni Merito with its unique approaches changing the way hiring is done.

What are looking for?
- You are keen on understanding customer's hiring trends and companies current hiring
- You're excited about identifying and reaching our to the prospects
- You're proficient in Microsoft Office applications and tool like CRM, Hubspot to curate the prospect data and be on the top of it
- You're good at communicating with prospective clients on email and phone to maintain a healthy relationship
- You should always be in hunting mode and leveraging different data sources to identify prospects
- Your interpersonal skills and knowledge in Customer Relationship Management (CRM) Software, get us to the top
- You're always ready for the future and always focuses on trying new approaches

Requirements :
- To create new client opportunities, its in your hands to research, identify and reach out to prospects
- You would be dealing with potential clients directly at all times to understand and managing their expectations
- You'd would understand client needs and suggest appropriate services to them
- The power lies within you to develop new relationships with potential clients, while maintaining existing client relationships
- You would be developing proposals for projects and also work on sales pitches and close deals with potential clients
- You're the key person who keeps a close look on the market and has an excellent understanding of the emerging market challenges.

Benefits :
- Fixed + variable pay
- Flexi work hours

Hello,

We are hiring SAP UI5 Developer with BTP experience for our client at Bangalore and Pune.

Roles and Responsibilities as follows:-

Experience – 4 to 8 years

Notice: Immediate to 7 days

Location – Pune or Bangalore

Must have willingness to travel to Pune office whenever needed.

Contract – is preferred or Fulltime is also ok.

Must Have

• Over 4 years of experience in working with SAPUI5

• Hands on experience and a good understanding in HTML, CSS and JavaScript

• Good Understanding of SAPUI5 framework and architecture

• End to end hand-on of SAP BTP Platform (SAP CF Service Offerings like, Destination, Portal/Launchpad, Object Store, Connectivity, Workflows. Etc).

• Experience in developing SAPUI5 application using ODATA service endpoint

. Experience in Standard and Custom SAP Fiori Applications

• Experience in Custom controls in SAP UI5 and Integration of 3rd party controls

• Experience in Application deployment on ABAP repo/ SAP CP

• Experience in Fiori Launchpad Portal configurations and application deployment.

Good to Have

• Experience in developing SAPUI5 application using Rest Web services endpoints

• Experience in ABAP OData services

• Experience in SAP HANA, SAP CP, SAP Cloud Foundry

• Experience in SAP CP Business Application using CDS

• Experience in SAP Multi Target Application

• Experience in Launchpad Theme Designing

Roles & Responsibilities :-

1. Create and optimize digital campaigns on Google Ads & Facebook

2. Prepare and setup Campaign proposals on Google Ads & Facebook platform (such as Search, Display & Remarketing)

3. Measures and reports performance of all digital marketing campaigns and assesses against goals (ROI and KPIs)

4. Positive & Negative Keywords Research & Analysis Quality Score PPC Bid Management, A/B testing of ads & landing pages

5. New Strategies & Recommendations (such as Ad Extensions, Custom audience, dynamic campaigns & dynamic re-marketing etc)

6. Brainstorms new and creative growth strategies through digital marketing

7. Measure and report performance of all marketing campaigns, and assess against goals

8. Identifying new business leads and contributing to the expansion of business activities

9. Preparing campaign budgets and work schedules, as well as setting project deadlines

10. Developing link building strategies.

11. Analyzing keywords and SEO techniques used by competitors.

12. Should play a major role in enhancing brand awareness within the digital space as well as driving website traffic and acquiring leads/customers

Skills Required :-

1.At least 2 years of exp in the advertising industry.

2. leading and managing SEO/SEM

3. Experience in optimizing landing pages and user funnels

4. Experience with A/B and multivariate experiments & In-depth knowledge of Google Ads and Facebook Paid Ads

5. Solid knowledge of website and marketing analytics tools (e.g., Google Analytics, SEMRush, etc.)

6. Experience in setting up and optimizing PPC campaigns on all major search engines

7. Knowledge about LinkedIn Marketing

8. Proficiency in campaign management software, such as HubSpot Marketing

9. Extensive experience in client relationship management

• Firm grasp of the JavaScript (and TypeScript ) language and its nuances
• Knowledge of (functional or object-oriented) programming
• Ability to write well-documented, clean Javascript code
• Rock solid at working with third-party dependencies and debugging dependency conflicts
• Familiarity with native build tools.
• Understanding of REST APIs, the document request model, and offline storage
• Experience with automated testing suites.

Position: IT Auditor

Experience: 4-12 Years

Location: Pune

Key Skills Required:

CISA, CISSP, CISM, IT Audit, Technology Audit, IT Infrastructure Audit, Application Security Audit, Information Security Audit, Cyber Security Audit, Cloud Security, Ethical Hacker

Additional key words: Vulnerability assessment, Penetration Testing, ITGC testing, Cloud Computing,

IT AUDITOR is responsible to plan and perform the audit assignment starting from audit announcement, audit planning, field work, audit quality reviews, pre-closing / closing meetings with the respective Directors / Head of the Departments including writing of the audit report and its finalization as well as follow up of the audit actions. Additionally IT AUDITOR will also be responsible to:
•    Evaluate IT systems, processes and projects in place;
•    Determine risks to the Group’s information assets, and help identify methods to minimize those risks;
•    Ensure information management processes are in compliance with IT-specific laws, policies and standards;
•    Determine inefficiencies in IT systems, IT projects and associated management processes and
•    Consult in IT projects, new initiatives and organizational frameworks.

Description

Audit Planning

1)    Perform audits at Volkswagen Group entities. and other concerned Volkswagen Group Companies with focus on IT processes keeping the associated business risks in mind.
2)    Participate in the preparation of audit objective & scope document along with audit schedule based on the audit objective and timeline specified by Head of IT Audit India Hub.
3)    Participate in the preparation of work program

Audit Process

1)     Prepare and conduct preparatory interviews with the Directors and Heads of the audited departments to identify the processes to be assessed during the audit.
2)     Request and collect relevant audit data for analysis from respective business areas.
3)     Prepare audit matrix on periodic basis to record the audit field work and update the progress of the audit to IT Audit Manager and the Head of IT Audit Hub India.
4)    Define actions including relevant controls to mitigate the business risks identified based on the evidences provided during the audit.
5)    Organize and conduct pre-closing meetings with business areas to agree upon audit observations and relevant actions.
6)    Prepare and conduct closing meetings with the Directors / Heads of the Department for audited division to agree upon the audit observations, risks and proposed actions.
7)    Prepare the draft audit report and submit the same to the  IT Audit Manager and the Head of IT Audit India Hub for review.
8)    Ensure that adequate documentation is prepared for the audit assignment. Peer review changes are done before release of the final audit report to the business area.
9)    Contact business area to review the progress of the implementation of audit actions defined in the final audit report. Based on the review, write the status of the follow up and submit the same for upload in RIAS.
10)    Obtain necessary certifications / qualifications to support the job requirements by attending relevant trainings
11)    Support the conduction of unscheduled audits/special investigations and audits from the anti-corruption system.
12)    Relevant knowledge is shared among the team members.
13)    Consult in IT projects, new initiatives and organizational frameworks.
14)    Ensure information management processes are in compliance with IT-specific laws, policies and standards.
15)    Determine risks to the Group’s information assets, and help identify methods to minimize those risks.
16)    Evaluate IT systems, processes and projects in place.
17)    Determine inefficiencies in IT systems, IT projects and associated management processes.