Confluent Medical Technologies, a new operation in Chattanooga, recently started production. The company's primary capabilities include: Nitinol components, balloon expandable stents and balloon catheters, delivery systems, biomedical textiles, access kits, and guidewires.
They are looking for a Quality Engineer I to join the Chattanooga Team.
A qualified candidate will:
- Diagnose and resolve manufacturing and quality system issues
- Provide guidance and generate reports for topics involving statistical analysis, including sample size requirements, hypothesis testing, regression analysis, calculation of confidence / tolerance intervals, and Design of Experiments (DOE)
- Investigate and manage customer field complaints, SCAR’s and internal CAPA’s.
- Represent Quality Assurance for Non-Conformance Report dispositions, and coordinate monthly Oversight Review Board presentation
- Participate on cross-functional teams to develop new projects
- Revise and provide training to manufacturing documents and other quality-related topics
- Interface with customers and suppliers as needed for quality issues and project requirements
- Create and/or approve validation protocols and reports and other technical documents
- Follow all safety and production standard operating procedures.
- Examine incoming materials and finished goods by performing visual and dimensional inspection to determine if product meets specifications. Reject, segregate and report unacceptable materials.
- Document the inspection results by completing reports and logs.
- Review Lot History Records to ensure their completeness and correctness.
- Constant vigilance and implementation of GMP and GDP practices.
- Assist in gauge tracking, performing calibration activities, as needed.
- Identify and record problems relating to product, process and quality systems.
- Suggest actions for continual improvement to products, processes or systems and support the implementation of solutions.
- Communicate with manufacturing and engineering personnel regarding quality issues.
- Perform internal audits.
Please find additional details and apply through the job site.