Quality Associate III

Job Title: Quality Associate III
Location: Medina, NY 14103 (onsite)
Duration: 6+ Months (possibility of extension)

Shift: General Day shift.
Offered pay: $41/hr. on w2
 
Role Overview:
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.
 
Key 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.
   

Qualifications & Skills:

• Education: Bachelor’s degree required.
• Experience: 3–5 years in Quality or a related field, preferably in medical products or an FDA-regulated industry.
• Certifications: ISO Lead Auditor training preferred; CQE, CQA, or CSSBB desired 
   
• Technical Skills:
  • Proficient in reading technical drawings/blueprints.
  • Knowledge of FDA cGMP, 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.
• Soft Skills:
  • 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.
• Other Requirements:
  • Ability to travel as needed.
  • Physically able to stand/walk for long periods and lift up to 20 lbs.