Overview
Quality Assurance Review Specialist – Senior Jobs in Dublin, CA at Paxon Energy & Infrastructure
About Air Techniques, Inc.
Founded in 1962, Air Techniques, Inc. set out to manufacture first-rate products for the dental industry. Over 63 years later, Air Techniques has grown from a small company into a successful corporation. At our New York headquarters, we design and build two main groups of products: utility room and digital imaging products. Our products are manufactured in a vertically integrated factory where compliance with the Food and Drug Administration Good Manufacturing Practices is paired with stringent Quality Standards. In-house engineering staff designs our products for the dental market. We are proud to maintain the ISO-13485 registration certification which reinforces our pledge to quality and customer satisfaction. At Air Techniques, we have earned our reputation in the dental industry through our commitment to quality and ensuring customer satisfaction. We are proud that Air Techniques represents superior quality to dealers and dentists worldwide.
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.
Primary 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%
Education Requirements
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 preference, or any other characteristic protected by applicable federal, state, or local laws.
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Title: Quality Assurance Review Specialist – Senior
Company: Paxon Energy & Infrastructure
Location: Dublin, CA
