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Senior Software QA Engineer

2 weeks ago

Gurgaon, Haryana, India Boston Scientific Full time

About This Role

We are seeking a senior software QA engineer to provide quality engineering input to support manufacturing, manufacturing engineering, and R&D activities that involve the development or use of software products.

Key Responsibilities:

  • Develops, applies, revises, and maintains quality standards for software products that the company develops as part of finished products or in support of manufacturing, manufacturing engineering, or quality processes.
  • Actively participates in new product development, design review, and design control activities related to software products.
  • Develops and implements process and product software verification and validation activities with reference to external standards and regulations, such as FDA, ISO, IEEE.
  • Leads the activities associated with software products risk assessment.
  • Provides technical guidance and training to other department members in software QA engineering areas of expertise.
  • Controls and maintains the database for tracking defects associated with the products during the design life cycle.
  • Provides input to, defines, and approves product and process validations and reports.
  • Establishes requirements for installation and operational qualifications for new and replacement equipment.

Requirements:

  • Bachelor's degree in engineering with preference computer science.
  • 9+ years of experience in medical device R&D quality engineering, systems, and/or quality engineering supporting R&D projects, design assurance, and documentation.
  • Professional training and certification in quality management systems, including ISO 13485, risk management ISO 14971, design assurance/control, verification, and validation.
  • Sound understanding of medical device regulatory requirements for Class II and III medical devices.
  • Project planning - resourcing, timelines, quality, and budgets.
  • Skilled in implementing quality tools like design of six sigma, risk management, FMEA, FTA (Fault Tree Analysis).
  • Prefers candidates with CQE certification or similar training and experience.
  • Proficient in project management tools like MS project.
  • Experience in ISO 62304.