CAPA Quality Engineer, Manufacturing

Regulatory Jobs; Irvine (CA); Hybrid; USD 87,000 - 123,000; Full time

Benefits offered by this job

Benefits program

Competitive salary

Job summary

Edwards in Irvine, CA, seeks an Engineer II, Manufacturing Quality Assurance to support CAPA activities across the product lifecycle, partnering with Manufacturing, Quality, and Engineering to drive investigations, root cause analysis, and corrective actions.

Onsite role requiring a Bachelor's degree and 2 years of experience in a regulated medical device environment; CA base pay ranges $87k-$123k with competitive benefits.

Qualifications

• Bachelor's degree in Engineering or Science required.
• 2 years of hands-on experience solving manufacturing or quality challenges.
• Onsite presence required.

Responsibilities

• Lead CAPA investigations related to manufacturing quality and compliance issues.
• Perform root cause analysis and develop corrective actions.
• Monitor CAPA progress and verify effectiveness.
• Work with cross-functional teams to document risk management throughout the product lifecycle.
• Develop and maintain CAPA records, work instructions, and training materials.
• Support CAPA Review Board meetings and action follow-ups.

Skills

CAPA investigations

Root cause analysis

Lean Six Sigma

Problem solving

Regulatory compliance

Education

Bachelor's degree in Engineering or Science

Tools

MS Office Suite

MS Project

Job description

Edwards in Irvine, CA, seeks an Engineer II, Manufacturing Quality Assurance to support CAPA activities across the product lifecycle, partnering with Manufacturing, Quality, and Engineering to drive investigations, root cause analysis, and corrective actions.

Onsite role requiring a Bachelor's degree and 2 years of experience in a regulated medical device environment; CA base pay ranges $87k-$123k with competitive benefits.