Inspector I, Quality Control (THV) - Temp to Hire

JENAVALVE TECHNOLOGY INC • Irvine, CA

13d • Onsite

About The Position

Responsible for supporting the Quality department with quality control activities related to the manufacture of the THV. This is a temp-to-hire position located in Irvine, CA, within a controlled cleanroom environment.

Requirements

• High school diploma or equivalent required. Candidates without a diploma may demonstrate equivalent competency through a validated external assessment designed to evaluate comprehension, language, and related abilities at a high school level.
• Must be familiar with 21CFR820 and ISO 13485 requirements.
• Must be able to work effectively and collaborate within cross-functional teams.
• Must possess the ability to handle multiple tasks, with high attention to detail.
• Ability to file and organize records in a compliant, easily retrievable manner.
• Must be able to effectively articulate (verbally and in writing) results and conclusions.
• Must have good documentation skills.
• Must be able to take initiative and work autonomously with the ability to prioritize a workload.
• Ability to read, comprehend and speak English, and good communication skills required.
• Proficiency with standard MS Office software applications, including Word, Excel, PowerPoint.

Nice To Haves

• Minimum of 1 year experience in Quality within the medical devices or pharmaceutical industries is desirable.
• Hands on experience with 21CFR820 and ISO 13485 requirements is preferred.
• Experience assessing products for compliance and final release is desirable.

Responsibilities

• Conduct routine testing on THV, to include functional, visual, and final inspection processes, along with supporting sterilization preparation.
• Conduct audits on the in-process paperwork associated with the manufacturing process including, but not limited to: manufactured valve DHRs, Jasmine preparation, and ancillary logs.
• Provide support to the Engineering staff by gathering data on commercial product to allow decisions to be made on functionality.
• Adhere to Quality System and record retention requirements.
• Comply with all site Health & Safety requirements.
• Contribute to continuous improvement efforts related to valve manufacture and inspection processes.
• Inspect final packaging labels and confirm they are applied correctly per the relevant standards and Work Instructions.
• Support other areas of the business as necessary and applicable to the role.
• Maintain reliable and consistent attendance to support production operations, including punctual arrival and the ability to work full scheduled shifts and overtime as required to meet operational and production needs.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED