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Philips · 1 day ago

Sr. QMS Engineer

Reedsville

Full-time

Onsite

Senior Level

$115K/yr - $160K/yr

5+ years exp

Philips is a health technology company dedicated to improving access to quality healthcare. They are seeking a Senior QMS Engineer responsible for the deployment and functioning of a compliant Quality Management System, analyzing QMS data, and presenting findings to leadership.

B2BConsumer ElectronicsElectronicsLightingWellness

No H1B

U.S. Citizen Only

Responsibilities

Takes ownership of moderately complex processes in the assigned area/ areas (Audits, Document Control, Training, CAPA) to ensure that QMS is efficient and meets the regulatory requirements

Analyzes and interprets QMS performance data to identify trends, process inefficiencies, and potential areas for improvement, and presents findings to management with recommendations for action

Acts as a key liaison between the QMS team and other departments to ensure effective communication, collaboration, and alignment of QMS activities with business objectives and regulatory requirements

Provides expert guidance and support to project teams in developing quality plans, risk assessments, and process validations to ensure compliance with QMS and regulatory expectations

Prepare for and participate in external regulatory audits and inspections by ensuring readiness of documentation, processes, and records, and provide responses to audit findings in collaboration with stakeholders

Qualification

Quality Management SystemsQuality AuditsCAPARisk ManagementMedical Device experienceAnalytical skillsCommunication skillsCollaboration skills

Required

Bachelor's / Master's Degree in Mechanical Engineering, Industrial Engineering, Science or equivalent

7+ years of experience with Bachelor's OR Minimum 5 years of experience with Master's in areas such as Quality Management Systems, Quality Audits or equivalent in highly regulated environments/industries such as MD, Pharma, Automotive

You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position