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
Email resumes to mrico@simplybiotech.com.
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
For immediate and confidential consideration, please email your resume to mrico@simplybiotech.com.
More information can be found at www.simplybiotech.com.
Principals only. Recruiters, please don't contact this job poster.