QA Officer

2 weeks ago


india IF MedTech Pvt Ltd Full time

At IF MedTech, we are dedicated to revolutionising healthcare through cutting-edge medical device design,

development, and pilot manufacturing. Our global team collaborates with experts across medical, engineering,

business, and research domains to bring innovative solutions that enhance healthcare and improve lives. Join us in our mission to drive innovation and make a global impact in the medical technology sector.


Responsibilities

Role and responsibility as QA - Quality Assurance Officer

  • Establishing, verifying and maintaining Software Quality Management System (QMS).
  • Develop and implement the Quality Management System (QMS) in line with ISO 13485, IMDR, 2017 and FDA QSR.
  • Create and maintain quality manuals, procedures, and work instructions.
  • Ensure the QMS covers all aspects of product development, manufacturing, and post-market activities.
  • Preparing Design History File

Other activities related to QMS:

  • Plan and conduct internal audits to verify QMS compliance with regulatory standards (ISO 13485, FDA, IMDR). Prepare for external audits (e.g., by Notified Bodies, FDA, CDSCO).
  • Manage supplier non-conformances and work with them to resolve issues in a timely manner.
  • Manage post-market surveillance activities to monitor product performance and safety once the product is on the market. Report adverse events to regulatory authorities as required (e.g., MDR, Vigilance Reporting).
  • Develop and conduct training programs for employees on quality assurance procedures, regulatory requirements, and compliance standards.


Qualifications

  • 3-5 years of experience in QA roles in the medical device industry.
  • Knowledge of ISO 13485, IMDR 2017, FDA QSR, EU MDR/IVDR and other global regulatory requirements.
  • Excellent understanding of product development lifecycle in the medical device industry.
  • Certified internal auditor as per ISO 13485
  • Demonstrated problem-solving abilities and a proactive approach to regulatory and technical challenges.
  • Strong interpersonal skills and the ability to work effectively in a collaborative, multidisciplinary team environment.
  • Commitment to quality, safety and compliance in all aspects of work.
  • Strong attention to detail and analytical skills.
  • Joining within 10 days

  • QA Executive

    4 days ago


    India CTRL M Full time

    CURRENT POSITION/JOB TITLE: QA Executive Location: Mumbai, Western Suburbs (2 min walk from the Railway Station) Job Description: QA Executive Job Type: Full-time Role Overview: We are looking for a motivated and detail-oriented Fresher for Website & Email QA to join our dynamic team. In this role, you will be responsible for ensuring the...

  • QA/QC Manager

    3 weeks ago


    india Tecnicas Reunidas Full time

    The ideal candidate will be Leading Quality activities at TREI, both at the corporate level and in projects, coordinating and supervising the QA and site QC activities. Candidate should possess at least 10 years of experience in Quality Management in Engineering Companies in the oil and gas sector, of which 5 years as QA/QC Manager. Responsibilities ISO...

  • Senior QA Tester

    1 month ago


    India Smart Working Full time

    Remote QA Tester OpportunityThis role is for a well-established UK digital firm who require a skilled QA Tester to work from home. As a senior member of their team, you'll have the opportunity to learn and develop new skills in a fast-paced environment.The business we are representing takes care of every aspect of digital transformation - from user research...


  • india IF MedTech Pvt Ltd Full time

    At IF MedTech, we are dedicated to revolutionising healthcare through cutting-edge medical device design, development, and pilot manufacturing. Our global team collaborates with experts across medical, engineering, business, and research domains to bring innovative solutions that enhance healthcare and improve lives. Join us in our mission to drive...


  • india CTRL M Full time

    CURRENT POSITION/JOB TITLE: QA Executive Location: Mumbai, Western Suburbs (2 min walk from the Railway Station) Job Description: QA Executive Job Type: Full-time Role Overview: We are looking for a motivated and detail-oriented Fresher for Website & Email QA to join our dynamic team. In this role, you will be responsible for ensuring the quality and...


  • India Edstem Technologies Full time

    Employees are required to be physically present in the office twice a month. Role/Responsibilities: Leadership and Coordination: Lead daily QA standups and other key project meetings to ensure alignment on project goals, testing priorities, and status updates. Cross-functional collaboration: Collaborate closely with developers, project managers, and...


  • india PCR Financial Aggregation Full time

    Only candidates based in Mumbai will be considered. Who is Private Client Resources (PCR)?PCR is a fast growing, dynamic, global FinTech company focused on changing the way wealthy families and their advisors view their financial assets and make financial decisions. PCR delivers a safe, efficient, and scalable technology platform to consolidate and globally...


  • india Panacea Biotec Full time

    JOB SUMMARY: Senior Scientific Officer- Validation (QA) shall be responsible for ensuring the quality and efficacy of vaccine formulations (Vaccine Drug Product Plant,Baddi). This position will be responsible for overseeing the Qualification/ validation of various Equipment/ System like HVACFilling line, Autoclave, Tunnel, Utilitiy systems, etc....


  • india Panacea Biotec Full time

    JOB SUMMARY: Senior Scientific Officer- Validation (QA) shall be responsible for ensuring the quality and efficacy of vaccine formulations (Vaccine Drug Product Plant,Baddi). This position will be responsible for overseeing the Qualification/ validation of various Equipment/ System like HVACFilling line, Autoclave, Tunnel, Utilitiy systems, etc....

  • QA Intern

    5 months ago


    India Atlan Full time

    A home for data teams around the world. Atlan makes it easier for diverse data users - business users, product managers, analysts, and engineers - to collaborate effectively. (Think of what Salesforce is for sales teams or GitHub for engineering teams). (Check out our website, product tour, and docs.) **Built for the humans of data, by the humans of...

  • Officer

    5 months ago


    India Kokuyo Camlin Full time

    Location - PATALGANGA - Business/Function - Not Specified - Band - Not Specified **Job Reference** - JR00000246 **Job Summary** - Job Summary not provided **Job Purpose** The purpose of the role is to inspect and drive quality of the products through the inspection of raw materials for finished goods manufactured at Patalganga Plant and supporting other...

  • Officer

    5 months ago


    India Kokuyo Camlin Full time

    Location - PATALGANGA - Business/Function - Not Specified - Band - Not Specified **Job Reference** - JR00000224 **Job Summary** - Job Summary not provided **Job Purpose** 1) Lab Testing & Evaluation. 2) Competitor product analysis & bench marking 3) Product Documentation 4) Certification 5) SAP Activities **Job Duties & Key Responsibilities** - Duties...


  • India Western Union APAC Full time

    **Associate, Quality Engineering ( Mobile Testing ) - Pune, India** Are you excited by the opportunity of using your knowledge of testing to success of Digital? Do you view Quality Engineering in the financial industry as more than just testing, and instead see it as an opportunity to improve money transfer experience? As a successful engineer, do you feel...


  • India Luxoft Full time

    Project Description: Group Technology and Operations (T&O) enables and empowers the bank with an efficient, nimble, and resilient infrastructure through a strategic focus on productivity, quality & control, technology, people capability, and innovation. In Group T&O, we manage the majority of the bank's operational processes and inspire and delight...


  • India Lister Digital Full time

    **About This Role**: **Overview**: We are seeking a talented Mid-Level Quality Assurance Engineer to join our team. As a Mid QA, you will play a pivotal role in ensuring the quality and performance of our products through both automation and manual testing. This position offers an opportunity to thrive in a collaborative environment and make significant...


  • India DMAIC Academy & Consultancy Full time

    Candidates should be okay to perform hands-on coding and code review. Position Overview: We are seeking a highly skilled and experienced QA Technical Manager to oversee and manage QA deliveries at our (Insert Location) office. The ideal candidate will be proficient in both manual and automation testing and have the ability to lead a team of QA ...

  • DMAIC Academy

    4 days ago


    india DMAIC Academy & Consultancy Full time

    Candidates should be okay to perform hands-on coding and code review. Position Overview: We are seeking a highly skilled and experienced QA Technical Manager to oversee and manage QA deliveries at our (Insert Location) office. The ideal candidate will be proficient in both manual and automation testing and have the ability to lead a team of QA professionals...

  • Automation QA

    1 month ago


    India Exavalu Full time

    Job Information Department Name SDET (Software Development Engineering in Testing) Date Opened 10/16/2024 Job Type Full time Job Location India Industry IT Services Remote Job About Us - Exavalu is a US based consulting firm specialized in Digital Transformation Advisory and Digital Solution Delivery for select industries like Insurance, Healthcare...

  • Salesforce QA

    6 months ago


    India Exavalu Full time

    Job Information Department Name Salesforce Cloud Job Location India Industry IT Services Remote Job About us - Exavalu is a US based consulting firm specialized in Digital Transformation Advisory and Digital Solution Delivery for select industries like Insurance, Healthcare and Financial Services. Our Headquarters is in California, US with multiple...


  • india Luxoft Full time

    Project Description: Group Technology and Operations (T&O) enables and empowers the bank with an efficient, nimble, and resilient infrastructure through a strategic focus on productivity, quality & control, technology, people capability, and innovation. In Group T&O, we manage the majority of the bank's operational processes and inspire and delight our...