Quality Assurance Engineer

3 weeks ago

Delhi, India Sol-Millennium Medical Group Full time
Purpose of the position

The Quality Assurance Engineer (QA Engineer) provides hands-on support of the Company's Quality Management System, in particular the complaint and CAPA management in our overall efforts to improve on our quality management system, be a strong advocate for our customers to resolve quality issues and achieve pre-market approvals. The QA Engineer Engineer’s primary responsibilities include assuring the full implementation of the complaint handling/vigilance system, compliance to international regulatory requirements, the implementation and maintenance of an effective communication with customers, support product distribution. The QA Engineer will also assure the maintenance of quality and regulatory documentation.

Responsibilities & duties:

Regulatory ComplianceEnsures regulatory compliance to applicable the relevant international country-specific requirements and policies.Maintains a state of compliance control for ISO13485, MDSAP, EU Medical Device Directives, EU Medical Device Regulations and Quality System RequirementsEnsures implementation of new and changing regulationsProvides documentation in support of regulatory submissions and customer requestsSupports implementation and execution of the regulatory compliance requirementsComplaints, CAPAs and NCRsTimely reporting the complaints into the document control platform (e.g. Greenlight Guru)Supports the complaint evaluation and investigation, including failure analysis.Reviews quality and manufacturing records, including DHRs, NCs, CAPAs, complaint records, failure analysis data and reports, and risk documentation.Supports trending and risk analysis; evaluate risk to patient.Assists or leads in the identification and activities of CAPAs and NCRsMaintains all relevant complaint handling and vigilance documents in a compliant mannerSubmit reportable events to regulatory agencies/ customersCommunicates effectively and in a timely manner to customersQuality AssuranceEnsure compliance with ISO 13485, MDD/ MDR and other applicable regulations and standardsEstablish, follow, and maintain Quality Management System procedures, work instructions, and other processesParticipate in the authorities’ inspections, ISO certification and surveillance audits and other auditsSupplier Quality AssuranceInteract and coordinate activities with other departments, external vendors, and customersSupport the suppliers/ vendors onboarding and sourcing processSupport and verifies the execution of the suppliers’ CAPAInternal and external auditsSupport internal, external, and customer audits of the SQA programPerform quality reviews, audits, investigations, and CAPAsIdentify areas of improvement and implement plans to correct and prevent problems.LeadershipIntegrate knowledge of the Quality Policy and Corporate Objectives into work practices to support the businessWork cross-functionally with Commercial, Sourcing, SQA, RA, R&D to assure high quality complaint investigationsLead the QA projects and promote the Quality and Regulatory Culture through the company

Academic & Formal QualificationsA diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devicesor four years of professional experience in regulatory affairs or in quality management systems relating to medical devicesknowledge of the medical devices EU regulationsknowledge of the ISO 13485 or ISO 9001 standardsASQ certification (Certified Quality Quality Engineer, Certified Quality Auditor, Certified Quality, Engineer)Work Experience & SkillsExperience in Quality Assurance for medical devicesGood working knowledge of the Microsoft OfficeWriting and approving standard operating procedures and work instructionsExperience in auditingExperience in the manufacturing and design of medical devicesExperience in the quality control and quality assurance of medical devices/ PPEproducts/ Biocides/ Cosmetics or Veterinary products

  • Quality Assurance Engineer

    1 week ago

    Delhi, Delhi, India NKG Infrastructure Limited Full time

    Job OverviewNKG Infrastructure Limited is seeking a highly skilled Quality Assurance Engineer to join our team. As a Quality Assurance Engineer, you will be responsible for ensuring that all construction activities are carried out in accordance with the company's quality policy and procedures.Key ResponsibilitiesConducting inspections of incoming materials...

  • Quality Assurance Engineer

    2 weeks ago

    Delhi, India Sol-Millennium Medical Group Full time

    Purpose of the positionThe Quality Assurance Engineer (QA Engineer) provides hands-on support of the Company's Quality Management System, in particular the complaint and CAPA management in our overall efforts to improve on our quality management system, be a strong advocate for our customers to resolve quality issues and achieve pre-market approvals. The QA...

  • Associate Quality Assurance Engineer

    4 weeks ago

    Delhi, India CareerXperts Consulting Full time

    We Are Hiring: Associate Quality Assurance Engineer Are you passionate about delivering high-quality software products? Do you have a keen eye for detail and a drive to ensure the highest standards in software development? Join our dynamic team as an Associate Quality Assurance Engineer and help us maintain excellence! Key Responsibilities: Execute...

  • Software Quality Assurance Engineer

    6 days ago

    Delhi, Delhi, India TechYantram Solutions LLC Full time

    Job Title: Software Quality Assurance EngineerOverview: At TechYantram Solutions LLC, we are seeking a skilled Software Quality Assurance Engineer to join our team. As a Software Quality Assurance Engineer, you will play a vital role in ensuring the quality and functionality of our software products.Key Responsibilities:Design and develop test plans, test...

  • Lead Quality Assurance Engineer

    2 weeks ago

    Delhi, Delhi, India SEDEMAC Full time

    About the RoleWe are seeking a highly skilled Lead Quality Assurance Engineer to join our team at SEDEMAC. As a key member of our Quality Assurance team, you will be responsible for leading the Customer Quality Assurance activities of the plant.Key ResponsibilitiesLead the Customer Quality Assurance activities of the plant, including executing CQA activities...

  • Associate Quality Assurance Engineer

    4 weeks ago

    Delhi, India CareerXperts Consulting Full time

    We Are Hiring: Associate Quality Assurance EngineerAre you passionate about delivering high-quality software products? Do you have a keen eye for detail and a drive to ensure the highest standards in software development? Join our dynamic team as anAssociate Quality Assurance Engineerand help us maintain excellence!Key Responsibilities:Execute manual and...

  • Quality Assurance Engineer

    2 weeks ago

    Delhi, Delhi, India 3M Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Engineer to join our team at 3M. As the face of Quality for various OEMs and Tier customers in the North region, you will work closely with them to understand their current, future, and potential Quality requirements and concerns. You will take up these concerns with the CFT to drive resolution...

  • Quality Assurance Specialist

    2 weeks ago

    Delhi, India ruttl Full time

    Company DescriptionRuttl is an AI-powered feedback tool that enhances collaboration across design, marketing, sales, and development teams. It improves operational efficiency and directly contributes to the business's bottom line.Role DescriptionThis is a full-time remote role for a Quality Assurance Specialist at ruttl. The Quality Assurance Specialist will...

  • Quality Assurance Specialist

    2 weeks ago

    Delhi, India ruttl Full time

    Company DescriptionRuttl is an AI-powered feedback tool that enhances collaboration across design, marketing, sales, and development teams. It improves operational efficiency and directly contributes to the business's bottom line.Role DescriptionThis is a full-time remote role for a Quality Assurance Specialist at ruttl. The Quality Assurance Specialist will...

  • Quality Assurance Specialist

    2 weeks ago

    Delhi, Delhi, India Macawber Beekay Pvt Ltd. Full time

    Job Title: Quality Assurance SpecialistMacawber Beekay Pvt Ltd. is seeking a highly skilled Quality Assurance Specialist to join our team.Job Summary:We are looking for a seasoned Quality Assurance Specialist with a strong background in quality management, inspection, and testing. The ideal candidate will have a deep understanding of quality standards,...

  • Quality Assurance Manager

    2 weeks ago

    Delhi, Delhi, India T&M Services Consulting Pvt Ltd Full time

    Job Title: Quality Assurance ManagerWe are seeking a highly skilled Quality Assurance Manager to join our team at T&M Services Consulting Pvt Ltd. As a key member of our organization, you will be responsible for ensuring the highest quality standards in our water proofing projects in Mumbai and Hyderabad.Key Responsibilities:Attend internal kick-off meetings...

  • Quality Assurance Specialist

    2 weeks ago

    Delhi, Delhi, India ruttl Full time

    Job DescriptionRuttl is an AI-powered feedback tool that enhances collaboration across design, marketing, sales, and development teams. It improves operational efficiency and directly contributes to the business's bottom line.Role DescriptionThis is a full-time remote role for a Quality Assurance Specialist at ruttl. The Quality Assurance Specialist will be...

  • Quality Assurance Automation Engineer

    4 days ago

    Delhi, Delhi, India Luxoft Full time

    Quality Assurance Automation EngineerAt Luxoft, we are looking for a Quality Assurance Automation Engineer to join our team. As a Quality Assurance Automation Engineer, you will be responsible for developing functional automation tests using Java-based test automation tools such as Selenium, Cucumber, and JUnit. You will also ensure automation testing...

  • Quality Assurance Specialist

    2 weeks ago

    Delhi, Delhi, India Macawber Beekay Pvt Ltd. Full time

    Job Title: Quality EngineerMacawber Beekay Pvt Ltd. is seeking a highly skilled Quality Engineer to join our team.Job Summary:We are looking for a Quality Engineer with 10+ years of experience in quality assurance, quality control, and quality management. The ideal candidate will have a strong background in mechanical engineering, excellent coordination...

  • Senior Quality Assurance Engineer

    2 weeks ago

    Delhi, Delhi, India Career Portal Full time

    Job Summary: We are seeking a highly skilled Senior Quality Assurance Engineer to join our team at Career Portal. The ideal candidate will have experience with Newgen iBPS QA Automation Testing and excellent communication skills. The Senior QA Engineer will be responsible for designing, developing, and executing test plans and test cases, as well as...

  • Senior Quality Assurance Engineer

    2 weeks ago

    Delhi, India TEKsystems Full time

    Senior Quality Assurance Engineering Job Description Senior Quality Engineer with a strong background in Data Quality and System Integration projects. The successful candidate will be responsible for designing and implementing quality assurance processes, executing testing activities, identifying defects, Automation Testing and collaborating with cross...

  • Senior Quality Assurance Engineer

    2 weeks ago

    Delhi, Delhi, India CliqHR Full time

    Job Title: Senior Quality Assurance EngineerCliqHR is seeking a highly skilled Senior Quality Assurance Engineer to join our team. As a key member of our QA team, you will be responsible for designing, creating, and executing automated test scripts using testing frameworks.Key Responsibilities:Design and develop comprehensive QA strategies, test plans, and...

  • Software Quality Assurance Engineer

    4 days ago

    Delhi, Delhi, India Kounsel Full time

    Software Quality Assurance EngineerWe are seeking a talented and motivated individual to join our team as a Software Quality Assurance Engineer. As a Graduate Intern, you will have the opportunity to gain hands-on experience in software testing and quality assurance.Key Responsibilities:Work closely with the product owner, UX designer, Development, and...

  • Senior Quality Assurance Engineer

    2 weeks ago

    Delhi, Delhi, India Career Portal Full time

    Senior QA Engineer Newgen IBPSWe are seeking a highly skilled Senior QA Engineer to join our team at Career Portal. The ideal candidate will have experience with Newgen iBPS QA Automation Testing and excellent communication skills.Key Responsibilities:Design, develop, and execute test plans and test casesDocument and track defectsCollaborate with...

  • Senior Quality Assurance Engineer

    1 week ago

    Delhi, Delhi, India RiskProfiler Inc Full time

    Job Title: Senior Quality Assurance EngineerThis is a remote position at RiskProfiler Inc.We are seeking a highly skilled and experienced Senior Quality Assurance Engineer to join our dynamic startup team. The successful candidate will be responsible for building and maintaining a comprehensive quality assurance system from the ground up. Additionally, they...