Senior Inspector , Quality Control; THV; 2nd Shift

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.

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.

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 21

CFR
820 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…