Senior QA Engineer Position

3 days ago

Kolkata Pune Delhi, India beBeeQualityEngineer Full time US$ 1,25,000 - US$ 1,75,000

We are seeking an experienced Software Quality Assurance Engineer to join our team. This role is responsible for ensuring the quality of our software products and services, from development through deployment.

The ideal candidate will have a strong background in software quality engineering, with experience in regulated industries such as medical devices or aerospace. They will be able to lead both internal and external audits, provide training on software quality engineering procedures, and implement systems that address evolving regulations.

Responsibilities
  • Ensure compliance with software procedures and guide teams on development life cycle appropriateness
  • Identify task dependencies and ensure effective development and maintenance efforts
  • Lead both internal and external audits for software quality systems
  • Provide training on ASP software quality engineering procedures to staff, contractors, and business partners
  • Lead compliance and risk management activities for software or system projects
  • Improve software quality processes based on industry trends and regulatory expectations
  • Ensure compliant, reliable systems prioritizing patient safety are transferred to users
  • Manage software change control in alignment with quality procedures and work instructions
  • Implement systems that address evolving regulations
  • Represent the Software Quality Engineering function during regulatory inspections
  • Recommend issue resolutions to senior management for compliance and capability concerns
  • Ensure Quality System Regulations are followed, including FDA, ISO13485, IEC 62304, ISO 14971, and Sarbanes-Oxley
  • Maintain documented evidence to validate that systems meet specifications and quality standards
  • Recommend updates to SOPs related to Computer Systems Validation (CSV)
  • Provide regulatory consulting, training, and assessments aligned with current requirements and trends
  • Lead continuous improvement in Software Development Lifecycle (SDLC) management
  • Convert business needs into validated, compliant solution designs
  • Act as a technical SME for CSV processes and regulatory audits worldwide
Requirements
  • Bachelor's degree in Engineering (Software, Computer Science, or Electrical) with 5+ years of experience
  • Graduate degree with 3+ years of experience
  • Relevant certifications such as ASQ CQE, CQM, or CQA preferred
  • Experience working in regulated industries (e.g., Medical Devices, Aerospace)
  • Strong understanding of GxP requirements and applicable standards
  • Experience with embedded software, ATE, data management, or product connectivity
  • Proficient in system development methodologies and software metrics
  • In-depth experience in software quality engineering practices and compliance processes
  • Knowledge of ISO 13485, 21 CFR Part 820, Part 11, ISO 14971, IEC 62366
  • Familiarity with configuration management, change control, testing (V&V), and issue tracking
  • Understanding of cybersecurity and data integrity requirements
  • Experience in managing projects and leading cross-functional teams
  • Risk mitigation and failure investigation experience
  • Skilled in troubleshooting and root cause analysis
  • Clear communicator with strong writing and presentation skills
  • Knowledge of embedded software or cloud SaaS applications
  • Strong leadership in driving SDLC and validation with cross-functional teams
  • Ability to manage consultants, vendors, and external partners
  • Excellent written and verbal communication skills
  • Proven ability to work independently and collaboratively
  • Competency in project management and change management practices

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