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Senior specialized regulatory QA role at Philips reduces applicant density.
Regulated medical-device validation expertise is highly domain-specific and not easily transferable.
Explicit 10-12 years requirement and regulated validation expertise make filters highly stringent.
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Own the development, review, and approval of validation plans, protocols, scripts, and reports for computerized systems to ensure compliance and functionality.
Verify software systems meet user, functional requirements, and intended use by applying risk-based validation principles and conducting risk assessments.
Manage validation documentation and evaluate system changes for validation impact while supporting CAPAs and continuous improvement initiatives within the validation program.
Bachelor's or Master's degree in Mechanical Engineering, Industrial Engineering, Science, or equivalent.
10-12 years of experience in Quality Management Systems, Quality Audits, or equivalent within a highly regulated industry.
Experience with compliance to regulatory requirements and industry standards related to computerized system validation.
Onsite role requiring full-time presence at company facilities; work location noted as company’s facilities.
Demonstrated expertise in computerized system validation within regulated environments, emphasizing risk-based validation techniques and compliance.
Experienced in managing end-to-end validation lifecycle including documentation, risk assessments, and CAPA support.
Capable of driving continuous improvement and process optimization within quality management and validation programs in a large, regulated health technology company.