Quality Engineer II – Medical Devices (Onsite Irvine)

Astrix Inc.; Irvine (CA); On-site; USD 55,000 - 61,000; Part time

Job summary

Astrix Inc. in Irvine, CA is seeking a Quality Engineer II to support medical device development with hands-on quality engineering across the lifecycle, partnering with R&D, Regulatory, and cross‑functional teams.

This onsite 12‑month contract with potential extension requires a Bachelor’s in Engineering or Life Sciences, 2+ years in medical device quality, and knowledge of ISO 13485/14971, design controls, V&V, and CAPA. Strong communication and problem solving are essential.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related technical field.
• 2+ years of Quality Engineering experience in the medical device industry.
• Experience with instrumentation or electromechanical product development in an ISO 13485 environment.
• Experience with design controls, risk management, change control, and V&V.
• Working knowledge of ISO 13485, ISO 14971, and medical device quality systems.
• Strong communication, collaboration, and independent problem-solving skills.

Responsibilities

• Support design controls, risk management, verification/validation, change control, and product transfer.
• Review and approve design control, risk management, V&V, and development documentation.
• Provide quality guidance and risk-based decision support to development teams.
• Assess product and process changes for quality and regulatory impact.
• Support deviation investigations, root cause analysis, and CAPA activities.
• Ensure compliance with ISO 13485, ISO 14971, GxP, SOPs, and applicable regulatory requirements.

Skills

Quality engineering

Design controls

V&V

CAPA

Problem solving

Team collaboration

Education

Bachelor’s degree in Engineering, Life Sciences, or related technical field

Tools

ISO 13485

ISO 14971

Job description

Astrix Inc. in Irvine, CA is seeking a Quality Engineer II to support medical device development with hands-on quality engineering across the lifecycle, partnering with R&D, Regulatory, and cross‑functional teams.

This onsite 12‑month contract with potential extension requires a Bachelor’s in Engineering or Life Sciences, 2+ years in medical device quality, and knowledge of ISO 13485/14971, design controls, V&V, and CAPA. Strong communication and problem solving are essential.