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.