QMS Software Engineer
23d ago

Job Description

In this role, you have the opportunity to

You will work within the global consumer products business managing the QMS compliance in the US and Canada and providing recommendations to management and functional business units.

Business sells Health Canada and FDA Class I and Class II products. A major focus of this position will be working within a global network to communicate and address QMS challenges applicable to the US, Canada and EU related to non-

You are responsible for

  • 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.
  • You are a part of

    You will report to the Head of Philips Quality Management System- BG Health and Wellness, headquartered in Amsterdam, Philips Personal Health team is made up of a highly talented and multi-

    national workforce that is approximately of 25,000 strong, and spans over 50 countries with sales in more than 100 countries.

    We are proud to claim market leadership positions for cutting edge solutions in the business areas of Personal Care, Oral Care, Shaving and Grooming, Mother & Child Care, and Coffee.

    Philips is home to popular brands such as Sonicare, AirFloss, Norelco, Avent, and Saeco.

    To succeed in this role, you should have the following skills and experience

  • Bachelor’s degree in engineering or IT related fields, preferred; advanced degrees are preferable in Quality, Regulatory or Software Engineering.
  • 3+ years of consistent experience in IT Software Validation methodology in regulated medical device, pharmaceutical and healthcare industry.
  • 3+ 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.
  • In return, we offer you

    Working in the medical industry brings much fulfillment, as well as unique challenges. As part of our HealthTech focused company, you will be responsible for successfully dealing with and managing Philips relationships with approval agencies such as the US Federal Drug Administration (FDA).

    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. Learn more by watching this video.

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