FUJIFILM Irvine Scientific is hiring for a Quality Assurance Manager. This team member will manage the Company’s Quality Assurance personnel and activities including incoming QA inspection raw materials, raw material qualification program, change notification, validation, final product release, customer audit management, and various customer and internal support as required. Ensure that requirements are met in all regulatory, compliance and registration functions as prescribed by the FDA’s GMPs (QSR), ISO 13485, MDD 93/42, MDR 2017/745, IVDD 98/79/EC, IVDR 2017/746, ISO 14971, Brazilian GMPs, Health Canada MDR, Australian Medical Device regulations and regulatory requirements for product registrations where products are distributed worldwide.
Manage QA Incoming Inspection function and personnel
Manage product Final Release function and personnel
Manage raw material qualification program including maintenance of data bases and records, and change notification.
Assist with customer audit program including scheduling, pre- and post-audit activities.
Provide customer support in areas such as completion of surveys, providing raw material information, and related QA support.
Assist in activities related to the preparation for and conduct of FDA and Notified Body inspections and customer audits.
Manage deviations, CAPA and associated actions and status
Assist and support Quality Systems management in the conduct of daily operations of the department and within the Company as required.
Trend and Analyze Quality Indicators. Provide input as to appropriate corrective and preventive actions and suggest plans for improvement.
B.S. in Microbiology/Chemistry/Biology/Chemical Engineering or equivalent experience preferred.
A minimum of ten (10) years of Quality Assurance in medical device manufacturing or equivalent.
A minimum of four years in a managerial position
Proficiency in current versions of MS Word, Excel
Excellent communication and collaboration skills
Ensure that requirements are met in all regulatory, compliance and registration functions as prescribed by the FDA’s GMPs (QSR), ISO 13485, MDD 93/42, MDR 2017/745, IVDD 98/79/EC, IVDR 2017/746, ISO 14971, Brazilian GMPs, Health Canada MDR.
Australian Medical Device regulations and regulatory requirements for product registrations where products are distributed worldwide.
Current industry regulations, i.e. Detailed understanding of 21CFR211-cGMP, FDA QSR 820, ISO13485, Canadian Medical Device Regulations, Brazil and inspection and auditing guidelines.
FUJIFILM Irvine Scientific is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.