Farmingdale, New York
- 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.
- 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.
- Bachelors degree in Engineering preferred
Job ID: 16074