Quality Engineer I, Medical Devices - Process & Validation

JenaValve Technology, Inc.; Irvine (CA); On-site; USD 80,000 - 100,000; Full time

Job summary

JenaValve Technology, Inc. is seeking an Engineer, Quality (THV) in Irvine, CA. The role involves providing quality engineering support for transcatheter heart valve manufacturing processes. Responsibilities include partnering with engineering, reviewing documentation for compliance, and leading root cause investigations for quality issues. Candidates should have a Bachelor’s degree in Engineering and at least 2 years of relevant experience in a regulated environment. Strong attention to detail and teamwork are essential for success in this position.

Qualifications

• Minimum 2 years of medical device quality/regulatory experience.
• Experience with nonconformances and investigations.
• Familiarity with 21CFR820 and ISO standards.

Responsibilities

• Provide technical quality support for manufacturing processes.
• Review documentation to ensure compliance with standards.
• Support and lead root cause investigations for quality issues.

Skills

Attention to detail

Regulatory compliance

Root cause analysis

Collaboration in teams

Education

Bachelor of Science degree in engineering or relevant scientific subject

Job description

JenaValve Technology, Inc. is seeking an Engineer, Quality (THV) in Irvine, CA. The role involves providing quality engineering support for transcatheter heart valve manufacturing processes. Responsibilities include partnering with engineering, reviewing documentation for compliance, and leading root cause investigations for quality issues. Candidates should have a Bachelor’s degree in Engineering and at least 2 years of relevant experience in a regulated environment. Strong attention to detail and teamwork are essential for success in this position.