FUJIFILM Holdings America Corporation · 3 months ago
QA In-Process Inspection Lead
US-CA-Santa Ana
Full-time
Onsite
Mid, Senior Level
$24.93/hr - $32.26/hr
2+ years expFUJIFILM Holdings America Corporation is a leader in life sciences, seeking a QA In Process Inspector Lead to ensure product quality through inspections and oversight of manufacturing processes. The role involves leading a team, coordinating issue resolutions, and maintaining compliance with industry regulations.
Artificial Intelligence (AI)Machine LearningMotion CapturePhotographyPrinting
Responsibilities
Provide work direction to and supervision of the QA In-Process Inspectors
Perform inspection activities (product, performance, training) in the manufacturing areas
Convene and coordinate deviation management activities
Follow and enforce GMP principles and company policies and procedures throughout the organization
Perform and coordinate with QA In-Process Inspectors facility walkthroughs to ensure company procedures are followed report any deviation immediately to department management
Built a collaborative and communications report with operations management
Attend daily production meetings and address production issues and report accordingly Review batch production records and perform associated activities (CoA’s, DB’s, error correction)
Inspect labeling and storage conditions of product
Assist in the updating of controlled documents (generating DCRs as needed)
Reviews and provide proposals for processes improvements as needed Maintain and update raw material inspection report database and prepare reports as assigned
Work independently and have effective communication skills
Accept/reject materials based on specifications
Assist/perform the release of final product
Qualification
Required
Associates Degree required
Basic understanding of microbiology and chemistry necessary
A minimum of two (2) years of Quality Assurance (record review or incoming inspection) in medical device manufacturer or equivalent
Computer skills necessary including Microsoft Word, Excel, PowerPoint, ERP systems
Detailed understanding of Current industry regulations, i.e. cGMP, FDA QSR 820, ISO13485, Canadian Medical Device Regulations, inspection guidelines, and general lab safety
Ability to speak, read, and write English
Good oral and communication skills
Preferred
Bachelor's Degree in a science discipline preferred
Benefits
Medical, Dental, Vision
Life Insurance
401k
Paid Time Off
Company
FUJIFILM Holdings America Corporation
For over 90 years, Fujifilm has found #ValueFromInnovation through expanding its portfolio to represent a broad spectrum of industries including medical and life sciences, electronic, chemical, graphic arts, information systems, industrial products, broadcast, data storage, and photography.
10001+ employees
H1B Sponsorship
FUJIFILM Holdings America Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2022 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2006-06-13Acquired
Leadership Team
Deepak Mahulikar
Chief Technology Officer
Patrícia Colombo
Chief Compliance Officer
Company data provided by crunchbase