Senior Quality Control Inspector - Medical Devices

JenaValve Technology, Inc.; Irvine (CA); Vor Ort; USD 25.000 - 40.000; Vollzeit

Zusammenfassung

JenaValve Technology, Inc. in Irvine, CA is seeking a Senior Inspector for Quality Control in THV manufacturing.

The role focuses on supporting QC activities, performing functional, visual, final, packaging inspections, and final release tasks in a controlled cleanroom environment. You will review DHRs, inspection records, GDP-compliant documentation, and participate in MRB reviews, ensuring compliance with 21 CFR 820 and ISO 13485.

Qualifikationen

• High school diploma or equivalent required.
• Minimum of 3 years experience in Quality within the medical devices or pharmaceutical industries is desirable.
• Must be familiar with 21CFR820 and ISO 13485 requirements. Hands on experience with these requirements is preferred.
• Experience assessing products for compliance and final release is required.

Aufgaben

• Perform Quality Control inspection activities related to THV manufacturing, including functional inspection, visual inspection, final inspection, packaging inspection, and final release activities, in accordance with approved procedures and production requirements.
• Support day-to-day QC inspection priorities by completing assigned inspection tasks accurately, efficiently, and in alignment with production schedules.
• Review in-process and finished product documentation, including manufactured valve DHRs, Jasmine preparation records, inspection records, and ancillary logs, as applicable, to ensure completeness, accuracy, and compliance with GDP requirements.
• Support review and release activities for THV Device History Records and final product release documentation in accordance with established quality requirements.
• Identify, document, and communicate inspection discrepancies, documentation errors, nonconforming material, or quality concerns in a timely manner to QC supervision, Quality Engineering, Manufacturing, or other applicable functions.

Kenntnisse

Quality inspection

Team collaboration

Documentation

MS Office

English communication

Ausbildung

High School Diploma

Tools

Vivitro

BDC

Jobbeschreibung

JenaValve Technology, Inc. in Irvine, CA is seeking a Senior Inspector for Quality Control in THV manufacturing.

The role focuses on supporting QC activities, performing functional, visual, final, packaging inspections, and final release tasks in a controlled cleanroom environment. You will review DHRs, inspection records, GDP-compliant documentation, and participate in MRB reviews, ensuring compliance with 21 CFR 820 and ISO 13485.