Supplier Quality Engineer

• 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
• 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

• 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%
• Bachelors degree in Engineering preferred

Experience in medical device industry

• Very generous benefits package
• Very welcoming work environment
• Cutting edge technology
• State-of-the-art, modern manufacturing facility