In this role, you have the opportunity to
Work within a global network to address and Quality System Software Controls applicable to the US, Canada and EU related to non-product software systems
You are responsible for
Establish lean practices around Quality System Software Controls for all shared or local QMS SW systems in line applicable policies and procedures
Ensure that software applications and related infrastructures are validated for their intended use by a controlled and documented process
Ensure that new software and changes to existing software or infrastructures are validated before approval and use
Ensure documentation of SW validation activities and results for all phases of the software system Life cycle including deployments and implementations.
Defines and establishes a lean practice (tools, methods, standards, competency, process and process performance) for SW validation & lifecycle control of new and existing SW systems.
Executes and /or manages SW validation & control activities.
Ensures 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.
Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends.
Follows processes and operational policies in selecting methods and techniques for obtaining solutions.
To succeed in this role, you should have the following skills and experience
5+ 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.
Demonstrated ability to interact and communicate (both oral and written) with junior project team/ organizational members, business leaders and senior executives.
Understanding of current inspectional practices of FDA, notified bodies and other regulatory agencies including previous interface with such bodies during regulatory assessments or inspections
Ability to apply current inspectional techniques to project documentation during the system lifecycle 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.
Competency in project management and the execution of multiple projects.
Demonstrated capability in critical thinking and leadership with strong abilities in relationship management.
Ability and willingness to travel 20% domestic and international.
In return, we offer you
Describe in two to three lines what tangible and intangible benefits the incumbent will gain in this role. Use our Employer Value Proposition (EVP) themes and information gathered in the RSM as input sources.
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 .
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.
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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