Q&R Validation Engineer
Job TitleQ&R Validation Engineer
Be a part of the Philips Quality Software Management Center of Excellence team working to define and deliver a new level of Software Validation Competency to the Health Tech community. Use your real-world experience and knowledge in software validation in a regulated environment to help shape the best practices and skills required to bring the organization to a Best in Class level.
Roles and Responsibilities
- Collaborate on the definition and training of the fundamental skills of software validation
- Development and maintenance of Software Validation Guidelines
- Provide support to project teams on software validation curriculum requirements
- Update and maintain software validation website
- Train others on the concepts of SW Validation and how it relates to the overall regulatory and compliance requirements of a medical device manufacturer
- Serve as liaison between the project managers and the Validation Competency Development team to regularly evaluate and update as needed the curriculum to meet project needs
- Support communication of the Validation Competency Model to the businesses and IT organization
What we are looking for:
In order to support the development of our Best-in-Class Software Validation Competency, the candidate should have:
- Demonstrated the ability to define and establish lean practices (tools, methods, standards, competency, process and process performance) for SW validation & life cycle control of new and existing SW systems
- Executed and/or managed SW validation & control activities
- Project level experience in ensuring the accuracy, completeness and compliance of SW validation deliverables by reviewing the SW validation packages of SW applications which automate Quality System processes
- Demonstrated the ability to author, review and/or approve SW validation deliverables for non-product SW, including but not limited to SW validation plans, requirements, test plans/protocols/results, risk assessments, traceability matrix and summary reports
- Experience training others on the concepts of SW Validation and how it relates to the overall regulatory and compliance requirements of a medical device manufacturer
- Bachelor’s degree (BSEE) in engineering and IT related fields; but any advanced degrees are preferable in Quality, Regulatory or Software Engineering.
- Development and/or delivery of training specific to Software Validation is desired
- 7+ years of consistent experience in IT Software Validation methodology in regulated medical device, pharmaceutical and healthcare industry.
- 5+ years of experience with IT software applications development and SDLC methodologies from requirements to validation (based on SDLC, IEEE and industry best practices).
- Expertise in validation of enterprise wide Quality IT systems using established Computer System Validation (CSV) methodology such as GAMP 5 and FDA guidelines.
- Strong background in FDA, ISO and EU regulations for medical devices and healthcare; especially FDA 21CFR Part 820/Part 11, ISO 13485 and EU Annex 1.
- Strong communication skills, proficiency in Power point or other presentation delivery tools.
- Experience with Learning Management Tools, such as Cornerstone OnDemand, is desired.
Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.
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.
In case of difficulties with your job application please send an email to [email protected]
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