At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

Software Quality Lead 

YOUR TASKS AND RESPONSIBILITIES:

• Responsible for lifecycle software quality oversight of Class 1 and Class 2 medical devices; primarily Software as a Medical Device (SaMD) and Software as a Service (SaaS).
• Ensuring adherence to applicable standards and regulations such as IEC 62304, FDA 21 CFR 820.30, and EU MDR.
• As a Project Core Team Member, provides E2E cross functional software lifecycle process guidance, expertise, and oversight.
• Reviews, supports, and ensures the integration of quality in all software lifecycle deliverables including requirements, software risk analysis, design, development, documentation, integration, test, verification, validation, and release to ensure process and Quality System compliance
• Oversees software milestone reviews as defined by the product development process.
• Leads Quality Element Teams for software development initiatives.
• Works hand-in-hand with Regulatory in both strategy development and execution across entire software lifecycle.
• Supports internal and external audits as required.
• Identifies and actively takes lead in process and Quality System improvements.
• Lead the implementation and maintenance of applicable software certifications (e.g.: Hitrust, EuroPriSe, ISO 27001)
• Support GxP validation activities
• Supports Software Supplier audits
• Supports Nonconformance and CAPA processes to assure timely and compliant assessments and processes of deviation and corrective/preventative actions.

WHO YOU ARE:

Required

• Bachelor’s Degree in Computer Science or Engineering
• 7+ years engineering, software engineering or software quality
• Functional knowledge and expertise in medical device software lifecycle processes, regulatory requirements, international standards, and software risk management.
• Working knowledge of applicable industry standards (e.g.: ISO 13485, IEC 62304, ISO 14971)
• Ability to manage multiple tasks/projects based on priorities
• Strong oral and written communication skills
• Strong collaborative/teamwork behaviors

Qualifications

• Knowledge of UI applications, Cloud based applications, database operations
• Other qualifications of interest include: 

• GDPR
• Artificial Intelligence
• Cybersecurity
• Cloud Computing
• Data Quality and Interoperability
• Data Security/Compliance (Hitrust, EuroPriSe, ISO 27001)

Ever feel burnt out by bureaucracy? Us too. That's why we're changing the way we work- for higher productivity, faster innovation, and better results. We call it Dynamic Shared Ownership (DSO). Learn more about what DSO will mean for you in your new role here

https://www.bayer.com/enfstrategyfstrategy

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