Quality Engineer

Overview:

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:

$80,000-$90,000K