Overview:

Since 2015, Resonetics has been growing rapidly. Through targeted acquisitions and greenfield investments, we have expanded into a global leader in advanced engineering, prototyping, product development, and micromanufacturing. Each of our locations is focused on specific manufacturing capabilities and technologies that provide a unique solution for the medical device and advanced diagnostic industries.

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