Senior Inspector I, Quality Control (THV) - 2nd Shift

JenaValve Technology, Inc.; Irvine (CA); Sur place; USD 34 440 000 - 55 104 000; Plein temps

Résumé du poste

JenaValve Technology, Inc. in Irvine, CA is seeking a Senior Inspector for Quality Control in THV manufacturing.

The role focuses on supporting QC activities, performing functional, visual, final, packaging inspections, and final release tasks in a controlled cleanroom environment. You will review DHRs, inspection records, GDP-compliant documentation, and participate in MRB reviews, ensuring compliance with 21 CFR 820 and ISO 13485.

Qualifications

• High school diploma or equivalent required.
• Minimum of 3 years 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 required.

Responsabilités

• Perform Quality Control inspection activities related to THV manufacturing, including functional inspection, visual inspection, final inspection, packaging inspection, and final release activities, in accordance with approved procedures and production requirements.
• Support day-to-day QC inspection priorities by completing assigned inspection tasks accurately, efficiently, and in alignment with production schedules.
• Review in-process and finished product documentation, including manufactured valve DHRs, Jasmine preparation records, inspection records, and ancillary logs, as applicable, to ensure completeness, accuracy, and compliance with GDP requirements.
• Support review and release activities for THV Device History Records and final product release documentation in accordance with established quality requirements.
• Identify, document, and communicate inspection discrepancies, documentation errors, nonconforming material, or quality concerns in a timely manner to QC supervision, Quality Engineering, Manufacturing, or other applicable functions.

Connaissances

Quality inspection

Team collaboration

Documentation

MS Office

English communication

Formation

High School Diploma

Outils

Vivitro

BDC

Description du poste

Job Title: Senior Inspector, Quality Control (THV)

• Senior Inspector I, Quality Control (THV)
• Senior Inspector II, Quality Control (THV)
• Senior 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

• Perform Quality Control inspection activities related to THV manufacturing, including functional inspection, visual inspection, final inspection, packaging inspection, and final release activities, in accordance with approved procedures and production requirements.
• Support day-to-day QC inspection priorities by completing assigned inspection tasks accurately, efficiently, and in alignment with production schedules.
• Review in-process and finished product documentation, including manufactured valve DHRs, Jasmine preparation records, inspection records, and ancillary logs, as applicable, to ensure completeness, accuracy, and compliance with Good Documentation Practice (GDP) requirements.
• Support review and release activities for THV Device History Records and final product release documentation in accordance with established quality requirements.
• Identify, document, and communicate inspection discrepancies, documentation errors, nonconforming material, or quality concerns in a timely manner to QC supervision, Quality Engineering, Manufacturing, or other applicable functions.
• Support Material Review Board (MRB) activities by providing inspection results, documentation review input, and product status information related to nonconforming material, as applicable.
• Perform inspection-related activities in support of Engineering, R&D, validation, process development, and special projects, as assigned.
• Assist with training, onboarding, and qualification of QC Inspectors by providing hands‑on guidance, procedure walkthroughs, inspection technique support, and feedback, as appropriate.
• Maintain certification and qualification for applicable QC inspection activities, including functional, visual, final inspection, packaging, and release‑related processes.
• Support adherence to Good Manufacturing Practices (GMP), Good Documentation Practice (GDP), document control, record retention requirements, and applicable Quality Management System procedures.
• Verify that inspection equipment, tools, fixtures, and work areas are ready for use, properly maintained, and within calibration or preventive maintenance requirements prior to use.
• Support preventive maintenance and calibration coordination for QC equipment, including Vivitro, BDC, or other inspection/test systems, as applicable.
• Provide clear and timely communication to QC supervision and cross-functional stakeholders regarding inspection status, documentation issues, product holds, release status, training needs, and quality concerns.
• Serve as a technical resource for QC inspection processes by demonstrating strong procedural knowledge, attention to detail, and consistent application of acceptance criteria.
• Ensure compliance with site Health & Safety requirements and maintain safe working practices within QC inspection areas.
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• Support broader business and departmental objectives as needed and perform other duties as assigned within the scope of 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.

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 3 years 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 required.

Skills And Abilities Required For This Job

• Senior Technicians demonstrate advanced technical proficiency and play a key role in maintaining production quality, supporting team development, and ensuring consistent process execution.
• 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.
• Requires the ability to perform work involving close visual attention and detailed product inspection.
• International travel may be required, as applicable to business and operational needs
• 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.
• Ability to lift or move materials up to 25 pounds.