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Philips · 8 hours ago

Quality Engineer

Latham, NY

Full-time

Onsite

Mid Level

$87K/yr - $126K/yr

3+ years exp

Philips is a health technology company dedicated to ensuring quality healthcare access for everyone. The Quality Engineer will guide the implementation of advanced process validation strategies and lead quality improvement initiatives while ensuring compliance with regulatory standards throughout the product lifecycle.

B2BConsumer ElectronicsElectronicsLightingWellness

No H1B

U.S. Citizen Only

Responsibilities

Develops and guides implementation of comprehensive process validation strategies, employing advanced statistical tools to ensure the seamless and compliant transition of new products into production, meeting both stringent quality and regulatory standards

Leads the entire design control process, from eliciting and validating design inputs to managing verification, validation, and design transfer activities, ensuring rigorous adherence to global regulatory requirements and quality standards across all product development stages

Leads strategic quality improvement initiatives by integrating quality, reliability, and Post Market Surveillance (PMS) insights into all stages of the product lifecycle, continuously enhancing product quality, reliability, and regulatory compliance

Conducts comprehensive assessments of product and system designs, critically reviewing performance data and leading root cause analyses to identify and rectify quality deficiencies, ensuring that design excellence is maintained and regulatory standards are met

Qualification

Process Quality ManagementCAPAMedical Device StandardsStatistical ToolsNew Product DevelopmentMechanical EngineeringElectronics EngineeringContinuous Improvement

Required

Bachelor's Degree in Mechanical Engineering, Electronics Engineering, Science or equivalent

3+ years of experience in Process Quality Management, CAPA, Medical Device manufacturing, Continuous Improvement

Experience in applying 21 CFR 820, ISO 13485, IEC 14971 and IEC 62304 and working knowledge with IEC 60601 and other relevant medical device standards

Experience with large Electro-Mechanical equipment, New Product Development

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