QA/RA Engineer

1 day ago

Thiruvananthapuram, Kerala, India Genrobotic Innovations Full time
We are seeking a motivated QA/RA Engineer to support the implementation, maintenance, and improvement of our Quality Management System (QMS) in compliance with global standards and regulations (ISO 9001, ISO 13485, IEC 62304, MDR). In this role, you will collaborate with cross-functional teams to manage documentation, assist in audits, support regulatory submissions, and promote a strong culture of quality across the organization. This position is ideal for candidates with 1–3 years of experience in quality assurance and regulatory affairs who are looking to expand their expertise and grow into a key contributor to compliance and business success.
 
Key Responsibilities:

·       Support in implementing, maintaining, and improving the QMS as per ISO 13485, ISO 9001, Indian MDR 2017, applicable standards and regulatory requirements.

·       Manage and control documents including version control and distribution.

·       Support in Engineering Change management (ECR/ECO process) and ensure compliance to procedures

·       Record, investigate, and track Nonconformances (NCs) raised across departments.

·       Support Root Cause Analysis and CAPA processes.

·       Follow up with responsible teams to ensure timely closure of actions and effectiveness verification

·       Prepare, coordinate, and support internal audits and external audits (ISO certification, regulatory audits, customer audits).

·       Assist in maintaining audit readiness and ensure compliance with requirements.

·       Provide assistance in preparing and maintaining technical documentation for regulatory submissions.

·       Stay updated on changes in standards and regulatory requirements applicable to company products

·       Collect, analyze, and present quality performance data (NC trends, CAPA status, audit findings).

·       Prepare reports for Management Review Meetings (MRM) and support decision-making through data insights

·       Assist in planning and conducting QMS trainings for employees on SOPs, CAPA, NC handling, and regulatory compliance.

·       Promote a quality culture across teams through regular engagement and awareness sessions

·       Work closely with R&D, Production, and Procurement to ensure compliance throughout the product lifecycle.

·       Participate in design reviews, risk management activities (ISO 14971), and process improvements

Required Skills :

  • Strong knowledge of ISO 13485, ISO 9001, ISO 14971, and Indian MDR 2017

  • Hands-on experience with quality data analysis, metrics tracking, and report generation

  • Competence in Nonconformance handling, CAPA management, and Root Cause Analysis tools

  • Strong skills in Document Control (SOPs, Work Instructions, Records) and version management

  • Familiarity with Internal Audits and Audit preparedness (ISO, Regulatory, Customer Audits)

  • Experience in Engineering Change Management (ECR/ECO process)

  • Awareness of medical device safety standards (IEC , IEC , etc.)

  • Strong analytical and problem-solving skills for quality investigations

  • High attention to detail and accuracy

  • Effective communication and interpersonal skills

  • Strong time management and organizational skills

  • Adaptability and ability to work effectively with cross-functional teams (R&D, Production, Procurement)

  • Skilled in report writing and presentation

Qualifications : B.Tech in Biomedical / Electronics / Electrical / related field
Experience: Years
Job Location :  Thiruvananthapuram
 

  • QA/RA Associate

    7 days ago

    Thiruvananthapuram, Kerala, India Genrobotics Full time

    We are seeking a motivatedQA/RA Associateto support the implementation, maintenance, and improvement of our Quality Management System (QMS) in compliance with global standards and regulations (ISO 9001, ISO 13485, IEC 62304, MDR). In this role, you will collaborate with cross-functional teams to manage documentation, assist in audits, support regulatory...

  • QA Engineer

    1 week ago

    Thiruvananthapuram, Kerala, India Reflections Info Systems Full time

    IntroductionWe are looking for 4+years experienced skilled QA Engineer with strong experience in Playwright automation, XRAY test management, and solid manual testing expertise. The ideal candidate will be responsible for ensuring product quality through structured test planning, robust automation coverage, and detailed manual validation across web...

  • Data QA Engineer

    1 day ago

    Thiruvananthapuram, Kerala, India Litmus7 System Consulting Full time

    5+ years of experience in Quality Assurance with at least 3+ years in Data QA.Design, develop, and execute manual and automated test cases for data ingestion, transformation, and consumption layers.Validate data completeness, consistency, and accuracy across diverse source and target systems.Write advanced SQL queries and supporting scripts to perform data...

  • QA/QC Engineer – MEP Construction

    3 days ago

    Thiruvananthapuram, Kerala, India emkay groups Full time

    Key ResponsibilitiesImplement and maintain the Project Quality Management Plan.Conduct inspections for HVAC, Electrical, Plumbing, Firefighting, and ELV systems.Review method statements, ITPs, material submittals, and shop drawings.Prepare QA/QC reports, WIRs, MIRs, NCRs, and corrective action records.Monitor testing & commissioning activities (pressure...

  • QA Engineer

    7 days ago

    Thiruvananthapuram, Kerala, India Finastra Full time

    Who are we?At Finastra, we are a dynamic global provider of open finance software solutions, dedicated to expanding access to financial services. Our innovative applications span Lending, Payments, Treasury and Capital Markets, and Universal Banking. Proudly serving over 8,000 customers, including 45 of the world's top 50 banks, we aim to boost financial...

  • QA Automation Engineer

    1 week ago

    Thiruvananthapuram, Kerala, India Equifax Full time ₹ 4,00,000 - ₹ 12,00,000 per year

    You are passionate about quality and how customers experience the products you test. You have the ability to create, maintain and execute test plans in order to verify requirements. As a Quality Engineer at Equifax, you will be a catalyst in both the development and the testing of high priority initiatives. You will develop and test new products to support...

  • Senior QA Engineer

    2 weeks ago

    Thiruvananthapuram, Kerala, India Guidehouse Full time

    Job Family:Application Testing (India)Travel Required:NoneClearance Required:NoneWhat Will You Do:Perform end-to-end testing and identify defects. Collaborate with developers and analysts to resolve issues. Maintain documentation of test results and quality metrics. Perform Database testing and identify defects What You Will Need  4+ years of...

  • Senior QA Tester

    2 weeks ago

    Thiruvananthapuram, Kerala, India Docme Cloud Solutions Full time ₹ 4,00,000 - ₹ 12,00,000 per year

    Role DescriptionWe are seeking an experiencedSenior QA Testerwith expertise in bothManual TestingandAutomation TestingusingJava and Selenium. The ideal candidate will be responsible for ensuring the quality and reliability of web and mobile applications by designing, executing, and maintaining comprehensive test plans and automation scripts.Key...

  • Senior QA Engineer

    3 days ago

    Thiruvananthapuram, Kerala, India Quest Global Full time

    Job Requirements At Quest Global, it's not just what we do but how and why we do it that makes us different. With over 25 years as an engineering services provider, we believe in the power of doing things differently to make the impossible possible. Our people are driven by the desire to make the world a better place—to make a positive difference that...

  • QA Engineer

    1 week ago

    Thiruvananthapuram, Kerala, India CareStack™ - Dental Practice Management Full time

    Responsibilities● Have an insatiable itch to join and the courage to scale an early-stage technology company.● Have 1+ years of experience in ensuring quality of modern day web platforms, using manual and automation techniques.● Have hands-on experience in a fourth generation programming language like C# or Java.● Are proficient in data structures...