Quality Engineer II

Job Summary

A company is looking for a Quality Engineer II Biomedical Device (Remote) Contract.

Key Responsibilities

• Draft and manage CAPAs, including conducting detailed root cause analysis
• Perform risk assessments, update Hazard Analyses, and maintain pFMEAs to ensure compliance with industry quality standards
• Produce clear, detailed, and accurate technical documentation

Required Qualifications

• Bachelor's degree in Biomedical Engineering or related technical discipline (preferred)
• More than 5 years of experience in Quality Engineering within the life sciences industry strongly preferred
• Hands-on experience with drafting and managing CAPAs, conducting risk assessments, and maintaining pFMEAs
• Detail-oriented, self-motivated, and able to manage workload in a remote environment