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Philips

Software Validation Engineer

Job TitleSoftware Validation Engineer

Job Description

Software Validation Engineer, Philips Healthcare, (Andover, MA , Highland Hts, OH, Best, Netherlands or US Home Based)

Summary Description:

To support ongoing Software Validation Program responsibilities within the Diagnostic Imaging (DI) Business Group in order to meet regulatory requirements in the validation of business applications.

Key Areas of Responsibility:

  • Lead system qualification effort and be the primary client contact for coordinating work, reporting status, resolving issues, and addressing change requests as they apply.
  • Responsible for ensuring the accuracy, completeness and compliance of validation deliverables by reviewing the validation packages. This includes providing oversight and assurance that validation documentation meets FDA regulatory, cGMP/GMP, and internal quality requirements.
  • Actively participate in the Validation Life Cycle of regulated projects by developing and driving validation deliverables in accordance with defined procedures, participating in application requirements definition, risk assessments, traceability matrix, validation protocol development, validation testing and deviation management; and working closely with cross-functional project teams across Healthcare in appropriate verification and validation testing requirements.
  • Support Quality & Regulatory Validation Operations group in following the established process and procedures for Validation in Healthcare business.
  • Provide guidance/feedback to business stakeholders in Validation compliance as per the applicable regulatory requirements and Philips Healthcare policies and procedures.
  • Work cross-functionally with IT, and the supporting businesses to implement improvements to computer systems; while adhering to the regulatory validation requirements, company QMS procedures, and industry best practices.
  • Serves as an active participant as CSV Subject Matter Expert in internal and regulatory inspections.
  • Work independently on and successfully solve problems and complete/qualify a system within given constraint of scope, time and schedule.

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Minimum Qualifications:

  • Bachelor's degree (BSc) in engineering or Science discipline; but any advanced degrees are preferable in Quality, Regulatory or Software Engineering. Willing to overlook lack of Bsc in lieu of relative technical experience
  • 7+ 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).

Desired Skills:

  • Expertise in validation of enterprise wide Quality IT systems using established Computer System Validation (CSV) methodology such as GAMP 5 and FDA guidelines.
  • Project Management and Supervisory Experience is a plus
  • Knowledge of cGMP and GDP requirements
  • 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.
  • Communicate globally, across teams and programs, from senior executives to administrative support personnel.
  • Experience working with remote teams.

Our Offer:

At Philips, we are driven by our mission to improve the lives of 3 billion people per year by 2025, and every day we move closer to achieving our goal by creating cutting-edge solutions that lead to confident diagnosis, improved care, and increased quality of life for patients. Thanks to our employees who share our passion for improving lives, we are at the forefront of the Healthcare industry leading in image guided interventions, ultrasound, patient monitoring, cardiology informatics, sleep therapy and respiratory care. Named one of the Top 50 Happiest Companies in America in 2013, we enable our employees to create a legacy in life through their work and support their development through people-centric learning, total rewards and personalized development planning programs.

Here at Philips WE ARE Working Together for a Better Tomorrow:

Philips' dedication to enriching lives is reflected in our company, our solutions, and a commitment to our people. Philips products lead to improved healthcare, faster diagnosis and better patient outcomes. Philips employees change lives every day.

Enjoy endless opportunities to learn, and develop your career in the directions to which you aspire. Philips Healthcare is a place where you will work with others whose far-reaching ideas and accomplishments have impacted over 200 million lives already. Please help us determine what's next. Your ideas and ability to deliver will help to transform the future of healthcare, and allow you to create your own legacy.

Thanks to our employees, we are at the forefront of the Healthcare industry. Healthcare providers, backed by our many market leading solutions, are able to diagnose confidently, improve care, and increase the quality of life for patients across North America each and every day.

Advance your career in an environment that supports work-life balance, health & well-being and continuous learning. Making a difference begins right here, where you come first.

Apply today!

Find out more info about Philips at www.philips.com/na/careers

Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.

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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Contact

If you forgot your password, you can click the Forgot Password button on the Sign In screen to reset it. In case of technical difficulties, please send an email to careersite@philips.com.

(Note: To ensure fairness and legal compliance in our recruitment processes, only technical issues will be monitored through the above inbox. Please do not submit resumes or applications to this email, as they will not be reviewed. Only applications received through the online application process will be considered.)

Job ID: c7b6a2f285ca3e07deb68f8913406b92
Employment Type: Other

Perks and Benefits

  • Health and Wellness

    • Health Insurance
    • Dental Insurance
    • Vision Insurance
    • Life Insurance
    • Short-Term Disability
    • Long-Term Disability
    • HSA
    • HSA With Employer Contribution
    • Fitness Subsidies
    • Pet Insurance
    • Mental Health Benefits
  • Work Flexibility

    • Flexible Work Hours
    • Remote Work Opportunities
    • Hybrid Work Opportunities
  • Office Life and Perks

    • Casual Dress
    • Snacks
    • On-Site Cafeteria
  • Vacation and Time Off

    • Paid Vacation
    • Paid Holidays
    • Personal/Sick Days
    • Volunteer Time Off
    • Summer Fridays
  • Financial and Retirement

    • 401(K) With Company Matching
    • Stock Purchase Program
    • Performance Bonus
  • Professional Development

    • Tuition Reimbursement
    • Promote From Within
    • Mentor Program
    • Shadowing Opportunities
    • Access to Online Courses
    • Lunch and Learns
  • Diversity and Inclusion

    • Diversity, Equity, and Inclusion Program
    • Employee Resource Groups (ERG)
    • Woman founded/led
    • Black founded/led
    • Latinx founded/led
    • Asian founded/led
    • LGBTQ+ founded/led
    • Veteran founded/led

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