Supplier Quality Engineer

Industry leading manufacturer with an outstanding history of success and longevity on Long Island, has an excellent career opportunity for a Supplier Quality Engineer. This is a great opportunity to jump on board with a company that offers a very welcoming work environment with cutting edge technology and a state-of-the-art, modern manufacturing facility along with a very generous benefits package!

Essential Functions and 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.
• Work with Quality Control to streamline incoming inspection process.

Work Experience Requirements:

• 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