Quality Engineer
Overview :
The Quality Engineer provides customer and factory facing quality support. The position includes managing the interface between Resonetics, its customers and suppliers quality organization, assisting with transition and sustaining of laser manufacturing processes, and support for our quality management system.
The Quality Engineer position uses Quality Engineering techniques including : Problem solving using Lean Six Sigma methodology, Process Validations and Verifications, Process Development and optimization, Gage R&R, and reducing dependence on inspection along with ISO 13485 and / or 21CFR820 compliance.
Responsibilities :
Liaising with customer quality personnel to resolve issues and Customer Complaints
Monitoring and disseminating customer quality report cards
Generating process deviations, Customer Change Notices, validation protocols & reports.
Assisting with troubleshooting of production processes Assisting with the PDP process
Leading development of metrology equipment
Developing and maintaining quality / control plans
Developing PFMECAs
Conducting Gage R&R studies
Resolving Corrective and Preventive Actions
Developing Quality Procedures and conducting training to all personnel as appropriate
Approving Nonconformance disposition
Analyzing production and validation data
Working on continual improvement and process assessment projects as assigned
Qualifications :
Minimum 2 years experience in a Quality Engineering role in a regulated and / or start-up company, or equivalent engineering experience
Demonstrated technical writing and communication skills. Working knowledge of Statistical software and / or Minitab Bachelor's degree or equivalent experience
Compensation :
Pay Range : $80,000-$90,000