Quality Control Engineer

1 week 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 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


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