Inspector , Quality Control; THV - Temp

Job Details

Location:

Irvine, CA 92618

Position Type:
Contractor

Education Level: High School

Salary Range: $24.20 - $24.20 Hourly

Job Title:

Inspector, Quality Control (THV)

Role Level: Individual Contributor

Supervisor/Manager

Title:

Supervisor, Quality Control

Job Location & Environment:
Irvine, CA–Corporate Office / Controlled Cleanroom Environment

Manufacturing - Hourly. Responsible for supporting the Quality department with quality control activities related to the manufacture of the THV.

• Conduct routine testing on THV, including functional, visual, and final inspection processes, and support sterilization preparation.
• Conduct audits on in-process paperwork, e.g., manufactured valve DHRs, Jasmine preparation, and ancillary logs.
• Provide support to Engineering staff by gathering product data to inform functionality decisions.
• 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 correct application per relevant standards and Work Instructions.
• Support other areas of the business as needed.
• Maintain reliable attendance and punctuality, including full scheduled shifts and overtime as required to meet operational needs.

• High school diploma or equivalent required; alternative competency may be demonstrated through a validated external assessment.
• Minimum 1 year experience in Quality within medical devices or pharmaceutical industries desirable.
• Familiarity with 21
  
  CFR
  820 and ISO 13485 requirements; hands‑on experience preferred.
• Experience assessing products for compliance and final release desirable.

• Effective collaboration within cross‑functional teams.
• Ability to handle multiple tasks with high attention to detail.
• Organized record filing and compliance.
• Strong verbal and written communication skills.
• Good documentation skills.
• Initiative and autonomy with prioritization abilities.
• Fluency in standard English.
• Proficiency with MS Office (Word, Excel, PowerPoint).

• Work in a controlled cleanroom environment with full gowning (gown/coveralls, gloves, mask, hairnet, boot covers, PPE).
• Prolonged periods of standing and sitting for inspection, testing, and review.
• Follow cleanroom, laboratory, and site safety protocols at all times.
• Use inspection and testing equipment as part of routine duties.
• Fine manipulation of small components with hands and fingers.
• Maintain close visual acuity.
• Lift, carry, push, or pull materials up to ~25 pounds.
• Stand, walk, sit for prolonged periods.
• Perform repetitive motions such as reaching and grasping.
• Ability to climb, twist, balance, stoop, kneel or crawl as needed.