Quality Engineer 3

Quality Engineer 3 Job Description Template

Our company is looking for a Quality Engineer 3 to join our team.

Responsibilities:

  • Works with customers during on site scheduled audits and visits;
  • Understand and implement FDA and other regulatory requirements as necessary;
  • Play an active role on quality management teams within the organization;
  • Act as the point of contact for statistical analysis;
  • Contribute to team effort by maintaining a positive outlook;
  • Work with quality management, manufacturing, and other functional groups on regulatory and quality system compliance;
  • Maintain, analyze and distribute required Quality Metrics;
  • Work cooperatively and effectively within a team environment to achieve common goals;
  • Perform complex technical analysis of quality data;
  • Prepare and present necessary information for Management Reviews;
  • Facilitate root cause analysis and corrective action identification;
  • Review manufacturing change, validation, and verification documents;
  • Collect and analyze quality data to identify areas for continuous improvement;
  • May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues;
  • Will also do consulting at client companies for extended periods of time.

Requirements:

  • Interfaces with staff, suppliers, and external subject matter experts to resolve technical issues;
  • Experience in medical device, pharmaceutical, or other regulated industry;
  • Communicate effectively both verbally and in writing;
  • Knowledge and ability to implement FDA or regulatory requirements as necessary;
  • Experience with FMEA and other risk documentation;
  • Understanding of and adherence to GMP practices and FDA regulations;
  • Understanding of Six Sigma and root cause analysis methodologies;
  • Requires demonstrated skills in the use of statistical tools for data analysis.