Our client is seeking a Quality Assurance Engineer near New York City!
Our client is a medical device company that specializes in developing and manufacturing heart failure instruments. They have many years in the industry and have seen continued success throughout battling serious heart failure. This position has a lot of potential for upward future growth. The primary responsibility of the Quality Assurance Engineer is to manage all field complaints and returned products. Additionally, this role will ensure that all the company’s products are designed and manufactured in conformance with the quality systems policies/procedures as well as the regulatory requirements.
- Troubleshoot and provide in-depth analysis of the returned products and reported non-conformities while maintaining communication with distributors for timely deliveries
- Initiate, perform, or oversee corrective and preventative actions, production updates, projects, ect. Based on field trend assessments
- Draft regulatory reports related to the field events as required and provide complaint history reports for regulatory submissions
- Lead verifications/qualifications and draft protocols/test reports
- Support R&D activities under design controls and support risk management activities
- Conduct management reviews and participate in Post-Market Surveillance meetings
- Participate in company audits and perform Quality Spot-Checks
- Support Material Review Board activities and company/vendor audits
- Prepare and support notifications of product/process changes to regulatory bodies & BSI
- Monitor and maintain the company’s quality systems, revise when necessary
- Bachelor’s degree in a relevant field and between 2-6 years of working in a quality assurance environment
- Experience in customer service is not required but is a plus