Air Techniques · 14 hours ago
Supplier Quality Engineer
Melville, NY
Full-time
Onsite
Senior Level
$85K/yr - $95K/yr
5+ years expAir Techniques, Inc. is a well-established manufacturer in the dental industry, known for its commitment to quality and customer satisfaction. The Supplier Quality Engineer ensures supplier compliance with regulatory standards, performs audits, and implements corrective actions to improve the Quality Management System.
Consumer GoodsHealth CareManufacturingMedical Device
Responsibilities
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. Assists or leads 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
Ideal candidate should possess good problem solving & 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 skills
Travel approximately 30%
Qualification
Required
5-7 years in manufacturing industry in Quality functions in an FDA regulated or equivalent industry
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 skills
Travel approximately 30%
Preferred
Experience in medical device industry highly desirable
Bachelors degree in Engineering preferred
Company
Air Techniques
Air Techniques is a medical devices company offering dental care products
201-500 employees
H1B Sponsorship
Air Techniques has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (1)
Funding
Current Stage
Growth StageLeadership Team
Esteban (Stefan) Reinhardt
GM & COO
Recent News
Company data provided by crunchbase