Software Quality Lead

At Bayer were visionaries driven to solve the worlds toughest challenges and striving for a world where Health for all Hunger for none is no longer a dream but a real possibility. Were 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 youre hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference theres 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

• Bachelors 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. Thats why were 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

Bayer does not charge any fees whatsoever for recruitment process. Please do not entertain such demand for payment by any individuals / entities in connection with recruitment with any Bayer Group entity(ies) worldwide under any pretext.

Please dont rely upon any unsolicited email from email addresses not ending with domain name or job advertisements referring you to an email address that does not end with . For checking the authenticity of such emails or advertisement you may approach us at