Philips QMS Software Validation Engineer 

South Africa, Free State, Dihlabeng Local Municipality 

463668183

QMS Software Validation Engineer
Job Description

As a Quality Management Systems Software Validation Engineer, you will execute and manage software validation and control activities by authoring, reviewing, and/or approving software validation deliverables for non-product software systems. This includes software validation plans, requirement test plans, protocols, results, risk assessments, traceability matrices, and summary reports, among others.

Your role:

• Monitoring software validation deliverables and activities for assigned NPSS (Non-product Software Systems) applications to ensure that regulations, protocols, procedures, and methodologies are followed, and that appropriate and complete documentation is captured and reported to support validation activities.
• Ensuring that new software and changes to existing software or infrastructures, are validated before approval and use by application of controls and risk management, in reviewing and approving change-control requests to assess potential quality system impact.
• Maintaining communication with the team to ensure understanding of schedule commitments, actual schedule durations, anticipated scope changes, and project risks associated with validation activities. Applying specialized and multi-functional skills, while gaining understanding of company policies and procedures to resolve complex issues in creative and effective ways.
• Providing guidance and feedback for regulatory requirements and Philips policies and procedures, while supporting external regulatory assessments and internal audits by providing validation documents and subject matter expertise.
• Supporting management and standardization of Quality Management System (QMS) processes in scope to ensure they are effective and compliant, while supporting the deployment of Non-product System Software validation process in the local Quality Management System, ensuring local and cross business harmonization, standardization and regulatory compliance.

You're the right fit if:

• You’ve acquired 5+ years of experience in IT Software Validation and IT software applications development. Experience within the medical device, pharmaceutical or healthcare industry, required.
• Your skills include:
  • expertise in validation of enterprise-wide quality IT systems using established Computer System Validation (CSV) methodology
  • strong knowledge of working with applications in automated technology (ex. 21 CFR including part 11, ISO 13485, and EU MDR, GAMP 5 and FDA guidelines)
  • experience with the deployment of Quality Management System processes
• You have a bachelor's degree in engineering or IT-related field (an advanced degree in Quality, Regulatory and Software Engineering – a plus).
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .
• You’re an excellent communicator, exhibit strong organizational skills and have demonstrated project management competency. You also apply current inspectional techniques to project documentation to ensure comprehensive documentation is created and maintained.

How we work together

This is an office role.

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

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The pay range for this position in Cambridge, MA is $89,000 to $153,000

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US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

within commuting distance to Cambridge, MA