Inspector , Quality Control; THV - Temp

Position: Inspector I, Quality Control (THV) - Temp to Hire
Job Title:

Inspector, Quality Control (THV)
Inspector I, Quality Control (THV)
Inspector II, Quality Control (THV)
Inspector III, Quality Control (THV)
Role Level: Individual Contributor Supervisor/Manager

Title:

Supervisor, Quality Control

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

Job Description

Summary:

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

Job 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.

Required

Education and Experience:

The level of this role (Technician I, II, or III) will be determined based on the candidate’s experience, technical skills, and demonstrated competencies relevant to the position.

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.

Minimum of 1 year experience in Quality within the medical devices or pharmaceutical industries is desirable.

Must be familiar with 21

CFR
820 and ISO 13485 requirements. Hands on experience with these requirements is preferred.

Experience assessing products for compliance and final release is desirable.

Skills and Abilities

Required for This Job:

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.

Physical Requirements:

Ability to work in a controlled cleanroom environment while wearing full cleanroom gowning including gown/coveralls, gloves, mask, hairnet, boot covers, and other PPE as needed.

Requires prolonged periods of standing and sitting to support inspection, testing, and review activities.

Must be able to follow clean rooms, laboratory, and site safety protocols at all times.

May require use of inspection and testing equipment as part of routine job duties.

Ability to use hands and fingers for fine manipulation of small components.

Ability to perform work requiring close visual acuity.

Ability to lift, carry, push, or pull materials and equipment weighing up to approximately 25 pounds.

Ability to visually inspect small components with or without corrective lenses.

Ability to work in a temperature-controlled environment with limited mobility while gowned.

Must be able to stand, walk, and sit for prolonged periods of time.

Must be able to push, pull, twist, climb, balance, stoop, kneel, and crawl.

Must be able to perform repetitive motions such as reaching and grasping.
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