Quality Engineer
: Job Details :

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