Quality Engineer

The Quality Engineer is the process owner for different quality systems (CAPA program, customer complaints, nonconformance, internal and external audits, risk management and so forth).

Responsibilities:

*Demonstrates critical thinking and problem-solving skills to address internal nonconformance, CAPA, customer complaints and continuous improvement project.

*Facilitates cross-functional collaborations to drive projects to completion within the established timeline.

*Benchmarks, improves and streamlines existing processes to achieve best-in-class status.

*Leads continuous improvement activities (individual effort or cross-functional team).

*Maintains current knowledge of ISO 13485 and FDA QSR requirements and applies to applicable Vesta processes.

Qualifications:

*Previous experience in medical device industry

*Bachelor's degree, preferably in a science or engineering-related discipline

*Willing to work in a team environment and contribute to group goals.

Considered a plus:

*Knowledge of ISO 13485:2016, FDA 21 CFR Part 820

*Experience with Statistical Process Control and Process Validation

*Certified Quality Engineer or Auditor (ASQ)