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 enviroment 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
Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.