Software Quality Assurance Engineer
In this role, you have the opportunity to
Ensure regulated automated tools used in the Quality System are appropriately validated and controlled through their life cycle from development, deployment, change control and retirement. This includes ensuring project teams adhere to processes and control mechanisms for software, hardware, data and relevant security to meet regulatory requirements.
You are responsible for
- Enforce policies and procedures for System Development Lifecycle Management control for use in Philips across all automated processes that drive, interface with, and provide data for the Quality System.
- Support development of the validation strategy and the validation effort from planning to retirement of Quality relevant systems and tools including interfaces to and from the system.
- Support regulatory and internal audits. Provide subject matter expertise during regulatory and partner inspection.
- Provide software quality assurance support in design and development of software solutions, and facilitate the application of controls and risk management by reviewing and approving IT change-control requests submitted by cross-functional project teams to assess potential quality system impact.
- Provide software quality assurance support when evaluating Off the Shelf Software validation to determine the validation strategy required to properly implement the software in the most effective and timely manner possible within the organization.
- Ensure that system development projects and changes to existing systems are conducted in compliance with the FDA Quality System Regulation and Medical Device Directives.
- Work alongside other validation professionals to gather data, plan activities, and obtain reviews and approvals of documentation including approving documentation with respect to software development life cycle policies and procedures.
- Assist in developing user, functional and technical requirements for IT systems.
- Provide guidance and support to personnel in their validation efforts, to ensure compliance.
- Provide GxP-related quality assurance oversight, with an emphasis on software validation.
- Track system life cycle deliverables and activities to ensure that regulations, protocols, procedures, and methodologies are followed, and that appropriate and complete documentation is captured and reported to support validation activities.
- Represent Quality & Regulatory Compliance and Control on cross-functional teams in support of SDLM activities.
- Advise technical personnel and management on regulatory compliance and interpretation and recommend appropriate corrective actions where needed.
To succeed in this role, you should have the following skills and experience:
- Must have 5+ years’ experience in validation of computer systems and systems security and control
- Experience working in disciplined regulated industry in the application of automated technology particularly 21 CFR, ISO 13485, GAMP 5
- Must have experience in maintaining an application in a validated state efficiently
- Minimum of 7 computerized systems implementations, comprised of multiple application types, in a regulated environment
- Demonstrated ability to interact and communicate (both oral and written) with junior project team/ organizational members, business leaders and senior executives.
- Expertise in IT protocols related to software/hardware validation, information security, data life cycle management
- Experience with evaluation of a vendor’s SaaS validation and determining the validation strategy required to be compliant when implementing Off the Shelf software
- Understanding of current inspection practices of FDA, notified bodies and other regulatory agencies including previous interface with such bodies during regulatory assessments or inspections
- Ability to apply current inspection techniques to project documentation during the system life cycle and prior to FDA inspection to ensure a comprehensive documentation package is created and maintained.
- Effective judgment and decision making skills, typically made under stressful situations
- Good communication skills is a must and ability to describe validation requirements clearly, concisely and in a convincing manner
- Competency in project management and the execution of multiple projects
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.
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As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.
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