Manufacturing Quality EngineerIn this role you have the opportunity to be A Quality Engineer supporting manufacturing in the Emergency Care Home and Public (ECHP) business. The quality engineer is responsible for leadership in the manufacturing area to ensure that products are made to business and customer expectations. They are accountable to the organization for their decisions and actions in this mission while also holding others accountable for the same. Working in the medical industry brings much fulfillment as well as unique challenges. As part of our HealthTech focused company you will be responsible for successfully managing Client relationships with approval agencies such as the US Federal Drug Administration (FDA).
Key Areas of Responsibility:
- NonConformance events including CAPA management Partner with Supplier Quality on incoming outgoing WIP Partner with Receiving Inspection /WIP inspection / FG Release Design transfer Resolve quality nonconformities with crossfunctional stakeholders Quality Management System Improvement Job Overview: Responsible with Change Management to manufacturing process or controls and: NC/QN Management Process.
- Analysis of defect for determining disposition of nonconformances Contribute to Operations performance monitoring reporting improvement and development. Lead and/or support improvement programs in factory.
- Assists Supplier Quality with investigations and may assist with Supplier Communications as required. Leads change management for process changes in the factory Responsible for nonconformance events and investigations Oversees Material Review board activities for nonconformance disposition management Acts as advisor to subordinates and crossfunctional partners to meet schedules and/or solve technical problems. Develops and administers schedules performance requirement
- Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors including an understanding of current business Trends. Follows processes and operational policies in selecting methods and techniques for obtaining solutions.
Education & Training:
- Bachelors degree in engineering science or equivalent experience Minimum of 5 years of related engineering experience (medical device or regulated industry preferred).
- Wideranging experience within an engineering function
- Well versed in Quality Engineering and Continuous Improvement techniques.1. Critical to business revenue related 2. Responsible for NCs CAPAs and sustaining manufacturing quality activities. Delay in hiring will results in compliance issues to NC and CAPAs and sustaining AED product line