In this role, you have the opportunity to
Establish lean practices around Quality System Software Controls for all shared or local QMS software systems in line applicable policies and procedures
Ensure that software application and related infrastructures are validated for their intended us by a controlled and documented process
You are responsible for
Defines and establishes a lean practice (tools, methods standards, competency, process and process performance) for software validation & lifecycle control of new and existing software system.
Ensure that new software and changes to existing software or infrastructures are validated before approval and use
Executes and/or manages software validation &control activities.
Ensures the accuracy, completeness and compliance of software validation deliverables by reviewing the software validation packages of software applications which automate Quality System processes.
Authors, reviews and/or approves software validation deliverables for non-product software, including but not limited to software validation plans, requirements, test plans, requirements, test plans/protocols/results, risk assessment, traceability and summary report.
You are a part of
To succeed in this role, you should have the following skills and experience
Education: Bachelor degree in engineering and IT related field, any advanced degrees are preferable in Quality ,Regulatory and software Engineering
Experience: More than 5 years of consistent experience in IT software validation methodology in medical industries. More than 5 years of experience with IT software applications development and SDLC methodologies from requirements to validation
Competencies and Skills
Expertise in validation of enterprise wide quality IT systems using established computer system Validation methodology such as GQMP t and FDA guideline
Strong background in FDA, ISO and EU regulations in medical devices industry
Fluent in English and Chinese Languages is required.
Strong interpersonal and influencing skills
Experience with working with cross-functional teams
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 .