72 applicants

Company

Original Job Post

Philips · 2 days ago

QMS Software Validation Engineer

Cambridge, MA

Full-time

Onsite

Mid, Senior Level

$77K/yr - $140K/yr

5+ years exp

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Responsibilities

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.

Qualification

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IT Software ValidationIT Software Applications DevelopmentComputer System ValidationGAMP 5FDA GuidelinesEnterprise-Wide Quality IT Systems ValidationFDA RegulationsISO RegulationsEU RegulationsMedical Devices RegulationsHealthcare RegulationsFDA 21CFR Part 820FDA 21CFR Part 11ISO 13485EU MDREU Annex 11

Required

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%