Quality Assurance Engineer
2 weeks ago
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 Compliance
- Ensures 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 Requirements
- Ensures implementation of new and changing regulations
- Provides documentation in support of regulatory submissions and customer requests
- Supports implementation and execution of the regulatory compliance requirements
Complaints, CAPAs and NCRs
- Timely 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 NCRs
- Maintains all relevant complaint handling and vigilance documents in a compliant manner
- Submit reportable events to regulatory agencies/ customers
- Communicates effectively and in a timely manner to customers
Quality Assurance
- Ensure compliance with ISO 13485, MDD/ MDR and other applicable regulations and standards
- Establish, follow, and maintain Quality Management System procedures, work instructions, and other processes
- Participate in the authorities’ inspections, ISO certification and surveillance audits and other audits
Supplier Quality Assurance
- Interact and coordinate activities with other departments, external vendors, and customers
- Support the suppliers/ vendors onboarding and sourcing process
- Support and verifies the execution of the suppliers’ CAPA
Internal and external audits
- Support internal, external, and customer audits of the SQA program
- Perform quality reviews, audits, investigations, and CAPAs
- Identify areas of improvement and implement plans to correct and prevent problems.
Leadership
- Integrate knowledge of the Quality Policy and Corporate Objectives into work practices to support the business
- Work cross-functionally with Commercial, Sourcing, SQA, RA, R&D to assure high quality complaint investigations
- Lead the QA projects and promote the Quality and Regulatory Culture through the company
Academic & Formal Qualifications
- A 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 devices
- or four years of professional experience in regulatory affairs or in quality management systems relating to medical devices
- knowledge of the medical devices EU regulations
- knowledge of the ISO 13485 or ISO 9001 standards
- ASQ certification (Certified Quality Quality Engineer, Certified Quality Auditor, Certified Quality, Engineer)
Work Experience & Skills
- Experience in Quality Assurance for medical devices
- Good working knowledge of the Microsoft Office
- Writing and approving standard operating procedures and work instructions
- Experience in auditing
- Experience in the manufacturing and design of medical devices
- Experience in the quality control and quality assurance of medical devices/ PPE
- products/ Biocides/ Cosmetics or Veterinary products
-
Quality Assurance Engineer
4 days ago
India CommScope Full timeQuality Assurance EngineerWe are seeking a highly skilled Quality Assurance Engineer to join our team at CommScope. As a Quality Assurance Engineer, you will be responsible for ensuring the quality of our products and services, identifying and resolving quality issues, and implementing process improvements.Key Responsibilities:Develop and implement quality...
-
Quality Assurance Engineer
5 days ago
India Sol-Millennium Medical Group Full timePurpose 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....
-
Quality Assurance Engineer
5 days ago
india Sol-Millennium Medical Group Full timePurpose 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...
-
Quality Assurance Engineer
1 week ago
india Sol-Millennium Medical Group Full timePurpose 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...
-
Quality Assurance Engineer
2 weeks ago
india Sol-Millennium Medical Group Full timePurpose 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...
-
Quality Assurance Engineer
1 week ago
India Sol-Millennium Medical Group Full timePurpose 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...
-
Quality Assurance Engineer
3 days ago
India Sol-Millennium Medical Group Full timePurpose 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...
-
Quality Assurance Engineer
1 month ago
india Self-employed Full timeCompany DescriptionWe are Leading Sheet Metal components, assemblies, welded parts manufacturing company for Automobile, Pump, Compressor industries.Role DescriptionThis is a full-time on-site role as a Quality Assurance Engineer located in Karad. As a Quality Assurance Engineer, you will be responsible for ensuring that our products meet the highest quality...
-
Associate Quality Assurance Engineer
3 weeks ago
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...
-
Quality Assurance Specialist
6 days ago
India Sol-Millennium Medical Group Full timeJob Title: Quality Assurance EngineerAbout the Role:We are seeking a highly skilled Quality Assurance Engineer to join our team at Sol-Millennium Medical Group. As a Quality Assurance Engineer, you will play a critical role in ensuring the quality and regulatory compliance of our medical devices.Key Responsibilities:Regulatory ComplianceEnsure compliance...
-
Quality Assurance Specialist
5 days ago
india ruttl Full timeCompany 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 Engineer
2 months ago
India Dexian India Full timeJob Role: Quality Assurance Engineer Experience: 3-6 years Notice period : Only Immediate joiners or currently serving notice less than 30-45 days. Kindly apply only if you have the following Mandatory Skills: *Selenium with C# *SQL *ADO *Process mapping tools. Technical expertise in: 2 years of manual testing and quality assurance experience 2+ years...
-
Quality Assurance Engineer
2 months ago
India Dexian India Full timeJob Role: Quality Assurance EngineerExperience: 3-6 yearsNotice period : Only Immediate joiners or currently serving notice less than 30-45 days.Kindly apply only if you have the following Mandatory Skills:*Selenium with C#*SQL*ADO*Process mapping tools.Technical expertise in:2 years of manual testing and quality assurance experience2+ years SQL...
-
Quality assurance specialist
5 days ago
India Ruttl Full timeCompany Description Ruttl 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 Description This is a full-time remote role for a Quality Assurance Specialist at ruttl. The Quality Assurance...
-
Quality Assurance Specialist
2 days ago
India ruttl Full time € 5,00,000 - € 7,00,000Company Description Ruttl 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 Description This is a full-time remote role for a Quality Assurance Specialist at ruttl. The Quality Assurance...
-
IT Quality Assurance Engineer
6 days ago
Anywhere in India/Multiple Locations HANDELNINE GLOBAL LLP Full timeJob Title: IT Quality Assurance EngineerAbout the Role:Handelnine Global is seeking an experienced IT Quality Assurance Engineer to join our Tech team. As a key member of our team, you will be responsible for ensuring the quality of our software applications.Key Responsibilities:Develop and execute test plans to ensure the quality of our software...
-
Manual Quality Assurance Engineer
1 week ago
india Intellofy Technologies Full timeJob Title: Manual Quality Assurance Engineer Experience: 2 - 4 years Location: Delhi (Hybrid) Job Type: Full-time Company Description Intellofy Technologies is a leading provider of offshore talent solutions located in the Greater Delhi Area. We specialize in offering dedicated, highly skilled resources to help businesses navigate the challenges of the...
-
Manual Quality Assurance Engineer
1 week ago
india Intellofy Technologies Full timeJob Title: Manual Quality Assurance Engineer Experience: 2 - 4 years Location: Delhi (Hybrid) Job Type: Full-time Company Description Intellofy Technologies is a leading provider of offshore talent solutions located in the Greater Delhi Area. We specialize in offering dedicated, highly skilled resources to help businesses navigate the challenges of the...
-
Quality Assurance Specialist
7 days ago
India ruttl Full timeCompany Description Ruttl 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 Description This is a full-time remote role for a Quality Assurance Specialist at ruttl. The Quality Assurance Specialist...
-
Quality Assurance Specialist
3 days ago
India ruttl Full timeCompany Description Ruttl 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 Description This is a full-time remote role for a Quality Assurance Specialist at ruttl. The Quality Assurance...