Quality Associate III Position Available In Orleans, New York
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Job Description
Quality Associate
III 4.0 4.0
out of 5 stars Medina, NY 14103 Job description: The Quality Associate III plays a key role in ensuring supplier quality compliance and performance across the supply chain. The position supports both sustaining and new product initiatives by collaborating with internal teams and suppliers to establish robust quality systems, process controls, and continuous improvement strategies. The role operates within a regulated FDA environment, requiring strong technical, analytical, and communication skills.
Responsibilities:
Drive overall supplier quality performance, including audits, validations, and corrective actions. Set expectations for supplier quality, process control, and continuous improvement. Participate in new product development teams to ensure quality integration. Conduct and coordinate supplier surveys, quality system audits, and process assessments. Collaborate with purchasing to monitor supplier metrics and support improvement plans. Work directly with suppliers to establish and maintain effective quality systems and root cause methodologies. Lead investigations related to non-conforming materials or components and perform CAPA. Validate supplier processes and components as needed. Support compliance through internal and supplier audits. Perform additional duties as assigned.
Requirements:
Bachelor’s degree required. 3-5 years in Quality or a related field, preferably in medical products or an FDA-regulated industry. ISO Led Auditor training preferred; CQE, CQA, or CSSBB desired Proficient in reading technical drawings/blueprints. Knowledge of FDA c
GMP, QSR, ISO 13485, CMDAS, ANSI/ISO/ASQC
standards. Hands-on experience with metrology, inspection, and analytical techniques. Proficient in MS Office Suite, Minitab, Access, and database systems. Strong problem-solving (CAPA), interpersonal, and communication skills. Ability to manage multiple tasks and work independently or in cross-functional teams. Capable of influencing management with minimal supervision. Ability to travel as needed. Physically able to stand/walk for long periods and lift up to 20 lbs.
