Software Validation Engineer
In this role, you have the opportunity to
Help build a high growth business that will help improve the lives of millions of people while advancing Philips journey as a global leader in Health Technology.
You are responsible for
- Define and establish a lean practice (tools, methods, standards, competency, process and process performance) for QMS software validation & lifecycle control of new and existing systems in line with applicable policies and procedures
- Execute and /or manage SW validation & control activities
- Ensure that new software and changes to existing software or infrastructures are validated before approval and use
- Ensure the accuracy, completeness and compliance of SW validation deliverables by reviewing the SW validation packages of SW applications which automate Quality System processes
- Authors, reviews and/or approves 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
- Support management and standardization of QMS processes in scope to ensure effective and compliant QMS. Lead deployment of Non Product System Software Validation process in the local Quality Management System, ensuring local and cross business harmonization, standardization and regulatory compliance
- Manage and improve compliance to FDA regulations and other Regulatory Agencies as required
- Business process expert for processes in scope, acting in support of the local business QMS lead and QMS element owners across the business to deploy harmonized and standardized Philips processes
- Support external and internal audit readiness and provide support during external and internal audits
- Actively participate in Quality & Regulatory initiatives as a cross functional contributor
- Drive local QMS transformation towards harmonized and standardized Philips QMS
- Demonstrate operational excellence and ensure quality in all deliverables
- Establish and ensure adherence to schedules, work plans
- Establishes local operational objectives and work plans
To succeed in this role, you should have the following skills and experience
- Bachelor’s degree plus a minimum of 5 years of related experience in the medical device or another regulated industry
- Experienced 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
- Proven experience in Quality Management System processes, including cross sector or business process standardization, ensuring effectiveness and efficiency while maintaining compliance with worldwide regulations
- An ability to successfully communicate and educate Quality Management System regulations, policies and strategies to teams at all levels of the organization
- Experience with deployment of Quality Management System processes as identified
- Project Management (development of project plans, status meetings, project reporting, etc.) and organizational change management;
- Cross functional team experience
- Communication in an organized and knowledgeable manner, delivering clear requests for information, demonstrating flexibility in prioritizing and completing tasks and communicating potential conflicts to a supervisor
- Manage time working on multiple projects simultaneously
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.
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.
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