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Job Information

Philips QMS Software Validation Specialist in Shenzhen, China


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

  • Professional QMS software validation Team, with multiple team peers globally.

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 .