Quality Engineer I – Medical Devices (THV)

Jenavalve Technology; Irvine (CA); On-site; USD 73,350 - 89,650; Full time

Job summary

Jenavalve Technology is looking for a Quality Engineer to provide Quality Engineering support for their Heart Valve manufacturing. The successful candidate will ensure compliance with QSRs and ISO standards while working in a cleanroom environment.

Key qualifications include a Bachelor's degree in a relevant field and at least 2 years of experience in medical device quality assurance. Strong analytical skills and collaboration are essential for success in this role.

Qualifications

• Minimum 2 years of medical device Quality/Regulatory experience required.
• Experience with nonconformances, risk analysis, and corrective actions is essential.
• Familiarity with 21CFR820 and ISO standards is needed.

Responsibilities

• Provide Quality Engineering support for transcatheter Heart Valve manufacturing.
• Partner with Manufacturing Engineers for process qualification.
• Audit the manufacturing line for compliance.

Skills

Attention to detail

Ability to work in cleanroom environment

Root cause analysis

Technical documentation

Collaboration within teams

Education

Bachelor of Science degree in engineering or relevant scientific subject

Tools

Inspection and testing equipment

Job description

Jenavalve Technology is looking for a Quality Engineer to provide Quality Engineering support for their Heart Valve manufacturing. The successful candidate will ensure compliance with QSRs and ISO standards while working in a cleanroom environment.

Key qualifications include a Bachelor's degree in a relevant field and at least 2 years of experience in medical device quality assurance. Strong analytical skills and collaboration are essential for success in this role.