Senior Inspector, Receiving (2nd Shift)

Irvine · On-site$30 – $30

About this role

Job DetailsJob Location: Irvine, CA 92618Position Type: ContractorEducation Level: High SchoolSalary Range: $30.80 - $30.80 HourlyJob Shift: OnsiteJob Category: QA - Quality ControlJob Title: Senior Inspector, Receiving

Senior Inspector I, Receiving

Senior Inspector II, Receiving

Senior Inspector III, Receiving

Role Level: Individual Contributor

Supervisor/Manager Title: Manager, Supplier Quality Assurance

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

Job Description Summary

Manufacturing - Hourly
Responsible for performing receiving inspections on incoming materials, ensuring compliance with specifications and quality standards. This role involves generating non-conforming reports and utilizing various measuring devices to assess product quality and working with engineers and supplier management personnel as needed.

Job Responsibilities

Perform Receiving Inspection tasks- mechanical, visual, and functional inspection of materials.
Use various measuring devices and testing equipment to assess product quality.
Maintain and file inspection reports/records.
Maintain the inspection area in a clean and orderly fashion.
Comply with all relevant quality management system policies and procedures.
Initiate Non-conformance Records (NCRs) and assist with material containment, root cause investigations and corrective actions.
Work closely/partner with engineers and supplier management personnel to resolve issues, non-conformances and CAPA (as applicable).
Participate in special projects, performing Test Method Validations (TMVs), protocols, first article inspection, etc.
Support the training of other inspectors through work demonstration and feedback.
Prioritize inspections based on business needs.
Participate in or lead process improvement initiates in the area.
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.
Other duties as assigned by manager.

QualificationsRequired Education and Experience

The level of this role (Senior 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 5 years’ experience on the job technical training in Quality Control or experience working within a quality management system in a highly regulated industry.
Working knowledge of Geometric Dimensioning and Tolerancing (GD&T).
Proficiency in using basic inspection tools such as calipers, micrometers, height gauges, and pin gauges.
Experience with vision measurement systems or similar inspection equipment.
Strong background in Good Documentation Practices (GDP).

Skills and Abilities Required for This Job

Must be able to work effectively and collaborate with cross-functional teams.
Must be able to effectively articulate (verbally and in writing) results and conclusions to technical and non-technical personnel.
Must have good documentation skills
Must take initiative and have the ability to conduct hands-on work.
Must possess the ability to handle multiple tasks with high attention to detail.
Broad knowledge of operational systems and practices.
Ability to read and interpret engineering drawings and specifications.
Continuously expands proficiency in inspection techniques.
Ability to use applicable tools and equipment, hand-eye coordination, and high manual dexterity.

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.
Ability to stand for extended periods during the work shift.
Ability to perform tasks requiring close visual acuity and attention to detail.
Ability to use hands and fingers to manipulate small tools and components.
Ability to lift or move materials weighing up to 25 pounds.
Ability to follow strict safety, contamination control, and cleanroom protocols
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.

Company at a glance

JenaValve is a medical device company developing the first transcatheter heart valve technology that is uniquely designed for the minimally invasive treatment of aortic regurgitation (AR).

The JenaValve Trilogy Heart Valve System is the first and only device currently approved in the EU for the treatment of severe, symptomatic aortic regurgitation in patients that are deemed high-risk for surgical aortic valve replacement. The Trilogy System is also CE-Mark approved for treatment of severe, symptomatic aortic stenosis.

In the US, JenaValve has completed enrollment of the ALIGN-AR IDE Clinical Trial which will support a future PMA submission. If approved, the Trilogy System would become the first and only TAVR system in the US indicated for the treatment of symptomatic, severe AR.

JenaValve is headquartered in Irvine, California with offices in Leeds, U.K. and Munich, Germany.

Founded2013
Team Size51-200 employees
WorkspaceOn-site
IndustryMedical Equipment Manufacturing
Location
Irvine, California, United States
LinkedInLinkedIn

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