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Senior Inspector, Quality Control (THV) - Simply Biotech

OVERVIEW

Are you looking for a new career opportunity with an exciting biotech company?! Then we have got the right team for you! In this role, you are responsible for the duties listed below.

Immediate opening for a Senior Inspector, Quality Control (THV) in Irvine, CA who possesses:

• High school diploma or equivalent required; candidates without a diploma may complete an employer-provided external assessment
• 3+ years of quality experience within the medical device industry
• Familiarity with 21 CFR 820 and ISO 13485 requirements
• Ability to stand for long periods of time

FULL DESCRIPTION: We are seeking a Senior Inspector, Quality Control to support quality control activities related to THV manufacturing in a controlled cleanroom environment. This permanent role is responsible for functional inspection, visual inspection, final inspection, packaging inspection, documentation review, DHR review, release support, discrepancy identification, cross-functional communication, and quality system compliance. The ideal candidate will have quality inspection experience within the medical device industry, strong documentation skills, familiarity with 21 CFR 820 and ISO 13485, and the ability to support inspection activities in a fast-paced cleanroom manufacturing environment.

The selected candidate will be responsible for:

• Performing quality control inspection activities related to THV manufacturing
• Performing functional inspection, visual inspection, final inspection, packaging inspection, and final release activities
• Completing assigned inspection tasks accurately and efficiently in alignment with production schedules
• Reviewing in-process and finished product documentation
• Reviewing manufactured valve DHRs, preparation records, inspection records, and ancillary logs for completeness and accuracy
• Supporting review and release activities for THV Device History Records and final product release documentation
• Identifying, documenting, and communicating inspection discrepancies, documentation errors, nonconforming material, and quality concerns
• Communicating issues to QC supervision, Quality Engineering, Manufacturing, and other applicable teams
• Supporting Material Review Board activities by providing inspection results, documentation review input, and product status information
• Performing inspection-related activities in support of Engineering, R&D, validation, process development, and special projects
• Assisting with training, onboarding, and qualification of QC Inspectors
• Providing hands-on guidance, procedure walkthroughs, inspection technique support, and feedback as appropriate
• Maintaining certification and qualification for applicable QC inspection activities
• Supporting adherence to GMP, GDP, document control, record retention, and Quality Management System procedures
• Verifying that inspection equipment, tools, fixtures, and work areas are ready for use and properly maintained
• Ensuring inspection equipment is within calibration or preventive maintenance requirements prior to use
• Supporting preventive maintenance and calibration coordination for QC equipment and inspection/test systems
• Providing clear and timely communication to QC supervision and cross-functional stakeholders
• Communicating inspection status, documentation issues, product holds, release status, training needs, and quality concerns
• Serving as a technical resource for QC inspection processes
• Demonstrating strong procedural knowledge, attention to detail, and consistent application of acceptance criteria
• Ensuring compliance with site Health & Safety requirements
• Supporting broader business and departmental objectives as needed
• Performing other duties as assigned

The selected candidate will also possess:

• 3+ years of quality experience within the medical device industry required
• Medical device or pharmaceutical quality experience required
• Heart valve, tissue, catheter, structural heart, or THV inspection experience strongly preferred
• Experience with first inspection, in-process inspection, final inspection, visual inspection, functional inspection, and packaging inspection preferred
• Experience assessing products for compliance and final release required
• Familiarity with 21 CFR 820 and ISO 13485 requirements required
• Hands-on experience with 21 CFR 820 and ISO 13485 preferred
• GMP and GDP documentation experience required
• DHR review experience preferred
• Experience working in a controlled cleanroom environment preferred
• Experience using inspection tools, fixtures, equipment, or test systems preferred
• Experience working under microscopes, lamps, or close visual inspection conditions preferred
• High school diploma or equivalent required; candidates without a diploma may complete an employer-provided external assessment
• Strong attention to detail
• Strong documentation skills
• Ability to file and organize records in a compliant and easily retrievable manner
• Ability to articulate results and conclusions verbally and in writing
• Ability to work effectively with cross-functional teams
• Ability to communicate professionally with Quality, Manufacturing, Engineering, R&D, and related departments
• Ability to handle multiple tasks and prioritize workload
• Ability to take initiative and work autonomously
• Ability to read, comprehend, and speak English
• Proficiency with Microsoft Office, including Word, Excel, and PowerPoint
• Basic Excel skills required
• Ability to maintain reliable and consistent attendance
• Ability to work onsite in Irvine, CA
• Ability to work 2nd shift from 2:30 PM to 11:30 PM after training
• Ability to train on 1st shift from approximately 5:30 AM to 2:30 PM for the first 3 to 6 months
• Ability to work overtime as required, including possible Saturdays
• Ability to support a permanent opportunity

Physical Requirements:

• Ability to work in a controlled cleanroom environment while wearing full cleanroom gowning, including gown or coveralls, gloves, mask, hairnet, boot covers, and other PPE as needed
• Ability to stand and sit for prolonged periods to support inspection, testing, documentation, and review activities
• Ability to follow cleanroom, laboratory, and site safety protocols at all times
• Ability to use inspection and testing equipment as part of routine job duties
• Ability to perform work requiring close visual attention and detailed product inspection
• Ability to work under a microscope, inspection lamp, or similar visual inspection conditions as needed
• Ability to push, pull, twist, climb, balance, stoop, kneel, and crawl as needed
• Ability to perform repetitive motions, including reaching and grasping
• Ability to lift or move materials up to 25 pounds
• Ability to push or move carts up to 20 to 30 pounds as needed
• Ability to work in an active manufacturing and cleanroom environment while following GMP, GDP, quality, and safety procedures

Salary Range: $24 to $31/hour
More information can be found at www.simplybiotech.com.

Simply Biotech was founded in 2008 and has been repeatedly recognized as one of San Diego County's fastest growing businesses. In 2025, we were named Business Journal's 'Best Places to Work'. Even as our competitors are scaling back and laying off staff, Simply Biotech is expanding to new markets and hiring additional staff in existing offices.