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QMS Software Validation Engineer

Company: Philips North America
Location: Cambridge
Posted on: June 4, 2024

Job Description:

Job TitleQMS Software Validation Engineer Job Description Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards creating a better and fairer future for all. In this role you have the opportunity to Support project teams by providing awareness, guidance and feedback on validation deliverables and test execution per Philips SDLM policies and procedures. Your role:

  • Assist project teams in creating validation documents including participating in developing application requirements and risk assessments.
  • Review requirements and design specifications for compliance to established validation processes and procedures, and for suitability as input for test protocols.
  • Create a traceability from requirement to test and identify the gaps in test coverage.
  • Support the project team during test execution to ensure compliance and assist in documenting deviations.
  • Act as independent observer during test execution to ensure GDP compliance and timely investigation and resolution of deviations; act as independent reviewer on test executions.
  • 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 application, 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, requirement test plans/protocols/results, risk assessments, traceability matrix and summary reports.
  • Applies specialized and multi-functional skills developed through job-related training and considerable on-the-job experience.
  • Applies company policies and procedures to resolve a variety of issues.
  • Frequently interacts with functional peer groups, demonstrating the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects or schedules.
  • Proficiency in a validation methodologies and has understanding of related validation processes.
  • Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
  • Ensures adherence to standards, procedures, guidelines and drives process improvements.
  • Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
  • Identifies problems in specific validations and proposes solutions.
  • Adaptive thinking in variable situations in order to analyze and interpret information
  • Works autonomously within established procedures and practices.
  • Normally receives general instructions on routine work, detailed instructions on new projects or assignments.
  • Accountable for validation deliverables for program level. You're the right fit if: US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
    • Bachelor's degree or diploma in technical/scientific discipline.
    • 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 using established Computer System Validation (CSV) methodology such as GAMP 5 and FDA guidelines.
    • 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/EU MDR and EU Annex 11.
    • Ability to travel up to 25% About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.
      • Learn more about our business.
      • Discover our rich and exciting history.
      • Learn more about our purpose.
      • Read more about our employee benefits. If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here. Philips Transparency Details The pay range for this position is $77,000,000 to $140,000, Annually. The actual base pay offered may vary depending on multiple factors including, job-related knowledge/skills, experience, business needs, geographical location, and internal equity. In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here. At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. Additional Information US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future. #LI-PHI This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration. Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.

Keywords: Philips North America, Cambridge , QMS Software Validation Engineer, IT / Software / Systems , Cambridge, Massachusetts

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