Supplier Quality Engineer

Join to apply for the Supplier Quality Engineer role at Air Techniques

Base pay range
$85,000.00/yr - $95,000.00/yr

Position

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.

• Perform regular supplier audits to ensure regulatory compliance
• Monitor and improve supplier quality and process performance
• Facilitate and perform on-site visits for root cause analysis
• Implement and verify corrective actions of supplier quality issues
• Create, monitor, and present supplier quality performance metrics
• Maintain accurate quality records for supplier management
• Develop 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 maintenance
• Review customer complaints, conduct product investigations, and ensure proper complaint closure
• Conduct medical device reporting assessments and process potential MDR reports
• Demonstrate good problem-solving and logical decision-making abilities
• Develop sampling plans for evaluating and reporting quality and reliability data
• Demonstrate continuous effort to improve product quality and manufacturing processes
• 5-7 years in manufacturing industry in Quality functions in an FDA regulated or equivalent industry; experience in medical device industry highly desirable; experience in supplier management
• Working knowledge of FDA regulations, cGMP, US-FDA’s 21 CFR Part 820, and ISO 13485:2016
• Strong MS Office skills
• Excellent communication, interpersonal skills, teamwork and problem-solving abilities
• Travel approximately 30%

• Bachelors degree in Engineering preferred

It 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.

• Seniority level:
  Mid-Senior level
• Employment type:
  
  Full-time
• Job function:
  Quality Assurance
• Industries:
  Medical Equipment Manufacturing