Supplier Quality Engineer
Air Techniques - Melville, NY
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Join to apply for the Supplier Quality Engineer role at Air TechniquesBase pay range$85,000.00/yr - $95,000.00/yrOverviewPosition Description: The Supplier Quality Engineer ensures supplier compliance with regulatory standards through audits, monitoring, and on-site root cause analysis. They implement corrective actions, track supplier quality metrics, and lead initiatives to improve the Quality Management System. This role involves reviewing customer complaints, conducting product investigations, and handling medical device reporting assessments. The ideal candidate has experience in supplier management and FDA-regulated industries, particularly in medical devices, with proficiency in relevant regulations and standards. Strong communication, teamwork, and problem-solving skills are essential. This position is based on site at our Melville, New York facility.Primary responsibilitiesPerform regular supplier audits to ensure regulatory complianceMonitor and improve supplier quality and process performanceFacilitate and perform on-site visits for root cause analysisImplement and verify corrective actions of supplier quality issuesCreate, monitor, and present supplier quality performance metricsMaintain accurate quality records for supplier managementDevelop new approaches to solve problems identified during quality assurance activities; assist or lead activities/projects to improve the Quality Management System, including coordinating, development, training and maintenanceReview customer complaints, conduct product investigations, and ensure proper complaint closureConduct medical device reporting assessments and process potential MDR reportsDemonstrate good problem-solving and logical decision-making abilitiesDevelop sampling plans for evaluating and reporting quality and reliability dataDemonstrate continuous effort to improve product quality and manufacturing processes5-7 years in manufacturing industry in Quality functions in an FDA regulated or equivalent industry; experience in medical device industry highly desirable; experience in supplier managementWorking knowledge of FDA regulations, cGMP, US-FDA’s 21 CFR Part 820, and ISO 13485:2016Strong MS Office skillsExcellent communication, interpersonal skills, teamwork and problem-solving abilitiesTravel approximately 30%Education requirementsBachelors degree in Engineering preferredIt is the policy of Air Techniques to provide equal employment opportunities to all qualified applicants without discrimination on the basis of race, creed, color, religion, national origin or ancestry, gender, citizenship, age, disability, marital status, veteran status, sexual orientation, or any other characteristic protected by applicable federal, state, or local laws.Job detailsSeniority level: Mid-Senior levelEmployment type: Full-timeJob function: Quality AssuranceIndustries: Medical Equipment Manufacturing #J-18808-Ljbffr
Created: 2025-10-06