Software Quality Specialist

4 weeks ago

India Wipro Full time
  • Overall experience - 7 to 10 years (Band B2 or B3).
  • Education: Bachelor's degree in computer engineering, Electronics, Electrical Engineering, or a related field

Primary skills set(must have):

  • 5+ years of experience in software or quality engineering in medical device development
  • 2+ years of experience in software quality management of Class 2 or Class 3 medical devices (SiMD or SaMD)
  • 2+ years of experience interpreting industry standards for medical device development and updating processes (ISO 13485, IEC 62304, IEC 82304, ISO 14971, FDA 21 CFR 820.30, EU MDR, FDA CFR Part 11, Annex 11, GAMP 5)
  • Ability to handle multiple tasks/projects and manage priorities
  • Strong technical writing skills.
  • Ensure software quality for radiology device products to meet FDA and regulatory standards. Oversee GxP-relevant computer systems' quality management
  • Responsible for software quality management of Class-2 medical devices, ensuring high-quality products that comply with FDA design controls and other regulatory standards

Position Duties & Responsibilities:

  • Manage software quality for Class-1 and Class-2 medical devices (SiMD and SaMD), including application, embedded, platform, and operating system software.
  • Ensure compliance with regulatory standards (FDA, IEC, ISO, EU MDR) for Radiology medical devices.
  • Evaluate software engineering activities (requirements, risk analysis, design, development, documentation, integration, verification, validation, release) to ensure safe, secure, and effective medical devices.
  • Review software lifecycle deliverables and provide timely feedback to stakeholders.
  • Ensure computer system validation initiatives comply with standards (FDA CFR Part 11, Annex 11).
  • Guide cross-functional teams to meet software quality objectives.
  • Engage in continuous improvement initiatives for Software Assurance (CoE, problem resolution, CAPA actions, process updates, audit support).

Preferences (Good to Have): Secondary

  • 2+ years in software development lifecycle phases
  • 2+ years programming in C, C#, Java, React JS, Angular
  • Knowledge of JIRA, AWS, GitHub, Rational Quality Manager, DOORS Next Gen
  • Familiarity with Windows and Linux
  • Experience in matrix/hybrid organizations
  • Strong troubleshooting and decision-making skills
  • Excellent communication and people skills
  • Proficiency with Microsoft Office tools

If the JD feels relevant request to share resume to below mail id -

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