Quality Assurance

5 months ago


Gurugram Haryana, India Human Capital Full time

Position - Quality Assurance Engineer (Medical Devices)

Industry Preferences - Medical Devices

Location - Delhi NCR

**Job Description -**

Risk Management, Design Inputs review, Design History File Document review, Design Output Document review, V&V protocols and reports review, Review and approval of CER.
- Participate in Risk Management per ISO14971 to ensure the safety and effectiveness of product.
- Responsible to ensure provisions of Design Control processes are followed and associated reviews are conducted.
- Participate in design reviews during various phases of NPD.
- Work with team to develop robust verification, validation & release strategies to ensure product compliance, safety, reliability & effectiveness.
- Expert-level knowledge of current industry standards for New Product Development and risk management practices.
- Solutions-based approach to quality engineering, wants to provide “added value" (“quality police” attitudes won’t survive in our culture).
- Exposure to any Programming language & on Software Testing concepts.
- Design And User Validation exposure.
- Good interpersonal and communication skills.

**Required Skills -**

Good understanding of Quality Management Systems. (ISO 13485, 21 CRF 820)
- AQE should drive coordination with different departments (such a R&D, Test, Regulatory, Clinical) to ensure the resulting part/product/process is safe, compliant and effective.
- Experience on NPD process and various phases of new product development.
- Knowledge of ISO 14971, IEC 62366, 60601-1 family of standards.
- Design and User Validation.
- Participant and/or champion for Corrective Action and Preventative Action (CAPA) process.
- Knowledge of IEC 62304 standard for Medical device software.
- Establish world class risk methodologies for complex systems based upon existing corporate/divisional approaches.
- Educate the organization in exceptional engineering processes & practices; including good documentation, formal design reviews and the other practices mentioned above.

**Job Types**: Full-time, Permanent

**Salary**: ₹1,300,000.00 - ₹1,800,000.00 per year

**Benefits**:

- Health insurance
- Provident Fund

Schedule:

- Day shift
- Fixed shift
- Monday to Friday

Supplemental pay types:

- Yearly bonus

Work Location: In person



  • Gurugram, Haryana, India Style Mart Impex Pvt Ltd Full time

    Responsible for quality assurance of sportswear and activewear garments at factory. - QC for Cutting, sewing, finishing - Conduct regular inspections of fabrics, filters, and finished products for defects or irregularities. - Min 3 years of experience is required. Pay: ₹250,000.00 - ₹400,000.00 per year Schedule: - Day shift Application...


  • Haryana, India Lonza Full time

    Job Title: Quality Assurance SpecialistRole Summary:We are seeking a detail-oriented Quality Assurance Specialist to join our team at Lonza. As a Quality Assurance Specialist, you will be responsible for ensuring that our products meet the highest standards of quality and safety.Key Responsibilities:Perform and monitor In-process Quality Assurance activities...


  • Haryana, India Lonza Full time

    At Lonza, we're driven by a passion for innovation and a commitment to excellence. As a Quality Assurance Specialist, you'll play a critical role in ensuring the highest standards of quality in our manufacturing processes.Key Responsibilities:Perform and monitor In-Process Quality Assurance activities during manufacturing stages to ensure products meet AQL...


  • Gurugram, Haryana, India Ethics Group Of Companies Full time

    **Responsibilities**: - **Regulatory Compliance**: - Stay abreast of current and evolving regulations related to Drug License and FSSAI requirements. - Ensure the organization's adherence to all applicable government regulations and standards. - **Drug License Application**: - Coordinate with regulatory authorities for timely approvals and compliance...


  • Haryana, India Lonza Full time

    Job Title: Quality Assurance SpecialistLonza, a global leader in life sciences, is seeking a Quality Assurance Specialist to join our team. In this role, you will be responsible for ensuring compliance with cGMP regulations and Lonza procedures.Main Responsibilities:Act as a subject matter expert for Data Integrity and GMP complianceAct as change manager to...


  • Haryana, India Trek Bicycle Corp (India) Full time

    Job Title: Quality Assurance SpecialistJob Summary:Trek Bicycle Corp (India) is seeking a Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our software products.Key Responsibilities:Work closely with team members to ensure understanding of acceptance criteriaWrite and...


  • Haryana, India Trek Bicycle Corp (India) Full time

    Job Title: Quality Assurance SpecialistJob Summary:Trek Bicycle Corp (India) is seeking a Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our software products.Key Responsibilities:Work closely with team members to ensure understanding of acceptance criteriaWrite and...


  • Gurugram, Haryana, India Geo Informatics Consultants Pvt. Ltd. Full time

    We are looking to hire Quality Assurance Executive. Location: Sonipat, Haryana **Job description**: **Key skills**: Thorough Knowledge of Medical Device Directive (MDD) 93/42/EEC, ISO 13485:2016, ISO 14971:2012 & Medical device Rules 2017 - Implementation and improvement in Quality Management System as per ISO 13485:2016. - Implementation & Formation of...


  • Gurugram, Haryana, India BlackRock Full time

    Description About this role Are you interested in building innovative technology that crafts the financial markets? Do you like working at the speed of a startup, and solving some of the world’s most exciting challenges? Do you want to work with, and learn from, hands-on leaders in technology and finance? At BlackRock, we are looking for Software...


  • Haryana, India Lonza Full time

    At Lonza, we value talented people working together to devise ideas that improve lives worldwide. As an In-Process Quality Assurance Associate, you will be part of a global leader in life sciences, operating across three continents.ResponsibilitiesPerform and monitor In-Process Quality Assurance activities during manufacturing stages to ensure products meet...


  • Gurugram, Haryana, India Talent Corner HR Services Pvt Ltd Full time

    **Here is an urgent opening for the Quality Assurance Executive at Textiles/Home furnishing/Decor manufacturing company.** **Location:Sector 34,Gurgaon** - Experienced in Home Textile industry quality procedures and standards viz. AQL, 4-point system, in-line, mid-line, final inspection - Knowledgeable of têxtile production processes such as weaving,...


  • Haryana, India Lonza Full time

    At Lonza, we're committed to delivering high-quality products and services that make a positive impact on people's lives. As an In Process Quality Assurance Associate, you'll play a critical role in ensuring our manufacturing processes meet the highest standards of quality and safety.Key Responsibilities:Perform and monitor In Process Quality Assurance...


  • Haryana, India Lonza Full time

    At Lonza, we're driven by a passion for improving lives through science. As an In-Process Quality Assurance Associate, you'll play a critical role in ensuring the quality of our products and services. Your expertise will help us deliver innovative solutions that make a meaningful difference in the world.Key Responsibilities:Perform and monitor In-Process...


  • Haryana, India Ensto Full time

    Job Title: Senior Quality Assurance EngineerEnsto is an international tech company creating smart solutions for electricity distribution networks. We are seeking a skilled Senior Quality Assurance Engineer to join our team.Job Summary:The Senior Quality Assurance Engineer will be responsible for managing and implementing end-to-end quality control and...


  • Haryana, India ConsultBae India Private limited Full time

    Job Title: Lead Quality Assurance EngineerAbout the Role:We are seeking a highly skilled Lead Quality Assurance Engineer to join our team in Gurugram. As a Lead QA Engineer, you will be responsible for executing test iterations, tracking and reporting test results, and troubleshooting and coordinating bug fixes. You will work closely with various...

  • Bombay Shaving Company

    5 months ago


    Gurugram, Haryana, India ConsultBae Full time

    **Manager**: Quality Assurance Cum Procurement **Location**:Gurgaon **Work Experience**:5+ years **Role Brief**: We are looking for an experienced Quality Assurance Cum Procurement Manager to manage the company’s supply of Products and Raw Materials. Quality Assurance Responsibilities include strategizing to find cost-effective deals and suppliers from...


  • Gurugram, Haryana, India Pathcare Diagnostics Full time

    Establish and implement quality management system across the diagnostic lab. Monitor and analyze the same for improvement. - Ensure the compliance of all the accreditation and certifications standards implemented in the system through close monitoring - Preparing and revising all the diagnostic lab policies, procedures, work instructions and department...


  • Haryana, India ConsultBae India Private limited Full time

    Job Title: Lead Quality Assurance EngineerWe are seeking a highly skilled and experienced Lead Quality Assurance Engineer to join our team at Neo Group, India's premier wealth management & asset advisory institution.About the Role:The successful candidate will be responsible for leading the quality assurance team in ensuring the delivery of high-quality...

  • Quality Assurance

    5 months ago


    Gurugram, Haryana, India Ethics Group Of Companies Full time

    Quality Systems Management: Develop, implement, and maintain quality systems and processes to ensure compliance with regulatory requirements, including Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Documentation Practices (GDP). - Document Control: Manage document control processes, including document creation, review,...


  • Haryana, India Trek Bicycle Corp (India) Full time

    Job Summary: Trek Bicycle Corp (India) seeks a skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the highest quality in our software products. Key Responsibilities: Work closely with the development team to ensure understanding of the acceptance criteria Develop and maintain...