Inspector I, Quality Control (THV) - Temp to Hire
JenaValve
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.
- 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.
- 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 21CFR820 and ISO 13485 requirements. Hands on experience with these requirements is preferred.
- Experience assessing products for compliance and final release is desirable.
- 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.
- 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.
Vacancy posted 4 days ago
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