Senior Inspector, Receiving (2nd Shift)
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JENAVALVE TECHNOLOGY INC
Irvine, CA, US
Summary
Perform mechanical, visual, and functional receiving inspections on incoming materials to ensure compliance with quality standards. Manage non-conformance reports, conduct root cause investigations, and collaborate with engineering teams to resolve quality issues.
Job Description
Job Details: Job Location: JenaValve Technology Inc-HQ - Irvine, CA, Position Type: Contractor, Education Level: High School, Salary Range: $30.80 - $30.80Hourly, Job Shift: Onsite, Job Category: QA - Quality Control, Job 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.
Qualifications: Required 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.
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.
Founded
2013
Company size
51-200 employees
Industry
Healthcare
Org type
Privately Held
Headquarters
Irvine, CA
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.
Founded
2013
Company size
51-200 employees
Industry
Healthcare
Org type
Privately Held
Headquarters
Irvine, CA