Quality Control Engineer

1 month ago

Bangalore Urban, India bigtec Private Limited Full time

Bigtec Labs is a wholly owned subsidiary and R&D arm of Molbio Diagnostics, a global MedTech company that is a pioneer in IVD (in-vitro diagnostics). We design and develop pathbreaking diagnostic platforms that address clinical need gaps and can be deployed in Point-of-Care, resource-limited settings.

Bigtec was established in the year 2000 in Bengaluru, the technology capital of India. We have grown to a multidisciplinary team of over 100 scientists and engineers, who excel in the translation of scientific ideas into market-ready products.

Our Mission: To develop cutting-edge products that enable precise, faster, cost-effective diagnosis at the Point-of-Care (POC)

Our Vision: To enable equitable access to healthcare by decentralization and democratization of diagnostic solutions


About the Role

We are looking for a dynamic and detail-oriented professional with 3 to 5 years of relevant experience in Computer System Validation (CSV), GAMP 5, GxP, and Quality Assurance for software development. This role will not only focus on ensuring software quality but will also involve liaising with external agencies for GDPR implementation and establishing the role of a data manager within our organization.

Key Responsibilities

Computer System Validation (CSV)

  • Assist in developing, maintaining, and executing CSV protocols and reports in compliance with industry standards, including GAMP 5 and GxP
  • Ensure validation documentation meets regulatory requirements and industry best practices
  • Perform risk assessments and maintain validation documentation

Software Development Life Cycle (SDLC)

  • Work closely with software development teams to understand project requirements and design test cases accordingly
  • Monitor and track software development processes to proactively identify potential quality issues
  • Implement and maintain quality control measures throughout the SDLC
  • Review and validate software documentation and deliverables

GDPR Implementation and Data Management

  • Liaise with external agencies to implement GDPR (General Data Protection Regulation) compliance measures within the organization
  • Act as a data manager, overseeing the collection, storage, and security of data in accordance with GDPR and other relevant regulations
  • Ensure data privacy and protection policies are in place and followed
  • Conduct regular audits of data management practices
  • Develop and maintain data protection documentation

Required Qualifications

  • Bachelor's degree / postgraduate degree in any discipline
  • 2 to 4 years of relevant experience in software quality assurance, CSV, GAMP 5, GxP, and SDLC
  • Strong analytical and problem-solving skills
  • Excellent communication and teamwork skills
  • Attention to detail and a commitment to delivering high-quality results

Preferred Qualifications

  • ISTQB certification
  • Knowledge of industry standards and regulatory requirements pertaining to software quality, validation, and data privacy (GDPR)
  • Experience with quality management systems
  • Understanding of data protection principles and practices
  • Experience in regulated industries

Technical Skills

  • Proficiency in quality management software
  • Knowledge of validation tools and methodologies
  • Understanding of database management systems
  • Familiarity with privacy impact assessments
  • Experience with documentation management systems


How to Apply


Send your most updated and relevant to Job Description CVs only to smitha@bigtec.co.in

  • Quality Control Engineer

    1 month ago

    Bangalore Urban, India bigtec Private Limited Full time

    Bigtec Labs is a wholly owned subsidiary and R&D arm of Molbio Diagnostics , a global MedTech company that is a pioneer in IVD (in-vitro diagnostics). We design and develop pathbreaking diagnostic platforms that address clinical need gaps and can be deployed in Point-of-Care, resource-limited settings. Bigtec was established in the year 2000 in Bengaluru,...

  • Quality Control Engineer

    4 days ago

    Bangalore, India GreenPole Power Solutions Full time

    The Company’s Equal Opportunities policy applies equally to the recruitment process and must be complied with at every stage of the recruitment process. This means that prospective applicants should not be discriminated against either directly or indirectly on the grounds of race, nationality, ethnic origin, gender, marital status, sexual orientation,...

  • Quality control engineer

    4 weeks ago

    Bangalore, India Bigtec Private Limited Full time

    Bigtec Labs is a wholly owned subsidiary and R&D arm of Molbio Diagnostics , a global Med Tech company that is a pioneer in IVD (in-vitro diagnostics). We design and develop pathbreaking diagnostic platforms that address clinical need gaps and can be deployed in Point-of-Care, resource-limited settings. Bigtec was established in the year 2000 in...

  • Quality Control Engineer

    1 month ago

    Bangalore, India bigtec Private Limited Full time

    Bigtec Labs is a wholly owned subsidiary and R&D arm of Molbio Diagnostics , a global MedTech company that is a pioneer in IVD (in-vitro diagnostics). We design and develop pathbreaking diagnostic platforms that address clinical need gaps and can be deployed in Point-of-Care, resource-limited settings. Bigtec was established in the year 2000 in...

  • Quality Control Engineer

    1 month ago

    bangalore, India bigtec Private Limited Full time

    Bigtec Labs is a wholly owned subsidiary and R&D arm of Molbio Diagnostics, a global MedTech company that is a pioneer in IVD (in-vitro diagnostics). We design and develop pathbreaking diagnostic platforms that address clinical need gaps and can be deployed in Point-of-Care, resource-limited settings.Bigtec was established in the year 2000 in Bengaluru, the...

  • Quality Control Engineer

    4 weeks ago

    Bangalore, India bigtec Private Limited Full time

    Bigtec Labs is a wholly owned subsidiary and R&D arm of Molbio Diagnostics , a global MedTech company that is a pioneer in IVD (in-vitro diagnostics). We design and develop pathbreaking diagnostic platforms that address clinical need gaps and can be deployed in Point-of-Care, resource-limited settings. Bigtec was established in the year 2000 in...

  • Quality Control Engineer

    1 month ago

    bangalore, India bigtec Private Limited Full time

    Bigtec Labs is a wholly owned subsidiary and R&D arm of Molbio Diagnostics, a global MedTech company that is a pioneer in IVD (in-vitro diagnostics). We design and develop pathbreaking diagnostic platforms that address clinical need gaps and can be deployed in Point-of-Care, resource-limited settings. Bigtec was established in the year 2000 in Bengaluru, the...

  • Document Controller

    1 month ago

    Bangalore Urban, India Capgemini Engineering Full time

    Job Description:The Document Controller is a member of the Quality department. S/he will liaise with all departments to provide the necessary document control and change management service in accordance with documented procedures. This position reports into the Site Quality Lead and is based in our Whitefield facility.Responsibilities:• Functional expert...

  • Document Controller

    1 month ago

    Bangalore Urban, India Capgemini Engineering Full time

    Job Description: The Document Controller is a member of the Quality department. S/he will liaise with all departments to provide the necessary document control and change management service in accordance with documented procedures. This position reports into the Site Quality Lead and is based in our Whitefield facility. Responsibilities: • Functional...

  • Quality Assurance Engineer

    2 weeks ago

    bangalore, India Smart Food Safe : Quality & Food Safety Management Software Full time

    Job Overview: As a Software QA, you will be responsible for ensuring the quality and reliability of our software products. Your role involves overseeing the entire software testing process, collaborating with development teams, and implementing best practices to deliver high-quality software to our users. Responsibilities:  Test Strategy and Planning:...

  • Quality assurance engineer

    2 weeks ago

    Bangalore, India Smart Food Safe : Quality & Food Safety Management Software Full time

    Job Overview: As a Software QA, you will be responsible for ensuring the quality and reliability of our software products. Your role involves overseeing the entire software testing process, collaborating with development teams, and implementing best practices to deliver high-quality software to our users. Responsibilities:  Test Strategy and...

  • Staff Software Quality Engineer

    1 month ago

    Bangalore Urban, India Advanced Sterilization Products Full time

    Office Address: #16 Salarpuria Premia (Opp. Cessna Business Park), Sarjapur Outer Ring Road (ORR), Bangalore 560103Applies advanced Quality Engineering/Scientific Method techniques and principles to all tasks and activities with a focus on software development projects. Applies relevant regulations, standards, GxP requirements, and industry best practices to...

  • Staff Software Quality Engineer

    1 month ago

    Bangalore Urban, India Advanced Sterilization Products Full time

    Office Address: #16 Salarpuria Premia (Opp. Cessna Business Park), Sarjapur Outer Ring Road (ORR), Bangalore 560103 Applies advanced Quality Engineering/Scientific Method techniques and principles to all tasks and activities with a focus on software development projects. Applies relevant regulations, standards, GxP requirements, and industry best practices...

  • Quality Assurance Engineer

    2 weeks ago

    bangalore, India Smart Food Safe : Quality & Food Safety Management Software Full time

    Job Overview:As a Software QA, you will be responsible for ensuring the quality and reliability of our software products. Your role involves overseeing the entire software testing process, collaborating with development teams, and implementing best practices to deliver high-quality software to our users.Responsibilities: Test Strategy and Planning:...

  • Quality Control Coordinator

    1 month ago

    bangalore, India Tecnicas Reunidas Full time

    Técnicas Reunidas is a world leading international general contractor engaged in the engineering and construction of industrial facilities in the fields of Oil & Gas, Petrochemical, Power Generation, Energy Transition, Infrastructures and industries, etc. Tecnicas Reunidas has worked and built all over the world, in 60 countries of the 5...

  • Lead Quality Assurance Engineer

    2 weeks ago

    Bangalore Urban, India SMC Squared India Full time

    Job Title : Lead QA Automation Engineer Location : Bangalore – Bhartiya City Tech Park Experience : 7+ Years Job Type : Full-time/ Permanent Notice Period : Immediate to 30 days Transportation : 2-way Cab Provided Job Summary: Papa Johns, a leader in digital innovation within the quick-service restaurant industry, is hiring a Lead QA Automation Engineer ....

  • Lead Quality Assurance Engineer

    3 weeks ago

    Bangalore Urban, India SMC Squared India Full time

    Job Title: Lead QA Automation EngineerLocation: Bangalore – Bhartiya City Tech ParkExperience: 7+ YearsJob Type: Full-time/ PermanentNotice Period: Immediate to 30 daysTransportation: 2-way Cab ProvidedJob Summary:Papa Johns, a leader in digital innovation within the quick-service restaurant industry, is hiring a Lead QA Automation Engineer. This role is...

  • Quality control coordinator

    1 month ago

    Bangalore, India Tecnicas Reunidas Full time

    Técnicas Reunidas is a world leading international general contractor engaged in the engineering and construction of industrial facilities in the fields of Oil & Gas, Petrochemical, Power Generation, Energy Transition, Infrastructures and industries, etc. Tecnicas Reunidas has worked and built all over the world, in 60 countries of the 5 continents. ...

  • Quality Control Coordinator

    1 month ago

    bangalore, India Tecnicas Reunidas Full time

    Técnicas Reunidas is a world leading international general contractor engaged in the engineering and construction of industrial facilities in the fields of Oil & Gas, Petrochemical, Power Generation, Energy Transition, Infrastructures and industries, etc. Tecnicas Reunidas has worked and built all over the world, in 60 countries of the 5...

  • Quality control associate

    1 month ago

    Bangalore, India BioTalent Search Private Limited Full time

    We are hiring for our rapidly growing client in the biotech IVD manufacturing business, based in Bengaluru. Job Title : QC Associate Location : Bengaluru Education and Experience : MSc in Biotechnology/ Molecular Biology. 3-4 years of industrial experience in Quality Control. Desirable : Expertise in QC for molecular diagnostic product...