Medical Device Quality Engineer - Onsite Hayward

Sibitalent Corp; Hayward (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

Sibitalent Corp in Hayward, CA is seeking a Quality Engineer (medical devices) for an onsite 12+ month contract. You will lead quality engineering activities within a regulated GxP environment, focusing on process validation and risk management.

The role requires a Bachelor's degree in Engineering and 3–5+ years in medical device quality, with hands-on experience in NCR/CAPA, root cause analysis, and documentation. Familiarity with CSV/software validation and SDLC is a plus.

Qualifications

• Bachelor's degree in Engineering or related field is required.
• 3–5+ years of Quality Engineering experience in medical devices.
• Hands-on experience with process validation and risk management.
• Strong documentation and communication skills in a regulated environment.
• Familiarity with NCR/CAPA, root cause analysis and continuous improvement.

Skills

Quality Engineering

Process Validation

Risk Management

Root Cause Analysis

Documentation Skills

Education

Bachelor's degree in Engineering

Master's degree in Engineering or MBA

Tools

CSV/Software Validation

Regulatory Compliance Tools

Job description

Sibitalent Corp in Hayward, CA is seeking a Quality Engineer (medical devices) for an onsite 12+ month contract. You will lead quality engineering activities within a regulated GxP environment, focusing on process validation and risk management.

The role requires a Bachelor's degree in Engineering and 3–5+ years in medical device quality, with hands-on experience in NCR/CAPA, root cause analysis, and documentation. Familiarity with CSV/software validation and SDLC is a plus.