We are hiring a QA Supervisor (2nd Shift) who 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.
Manage QA incoming inspection function and personnel
Manage product Final Release function and personnel
Manage raw material source and origin program including maintenance of data bases and records
Manage supplier and internal audit program including scheduling, pre- and post-audit activities
Manage and provide customer support in areas such as completion of surveys, providing raw material source and origin information, and related QA support
Assist in activities related to the preparation for and conduct of FDA and Notified Body inspections and customer audits
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, deviations, actions, and other related KPI’s to ensure efficient company function. Provide input as to appropriate corrective and preventive actions and suggest plans for improvement.
B.S. or B.A. preferred.
Five or more years of direct QA experience in the medical device and/or pharmaceutical industry
2+ years of supervisory experience
Proficiency in current versions of MS Word, Excel
Excellent communication and collaboration skill
Detailed knowledge of FDA’s GMPs (QSR), ISO 13485, MDD 93/42, IVDD 98/79/EC, Health Canada, and MDR requirements
Current industry regulations, i.e. Detailed understanding of 21CFR211-cGMP, FDA QSR 820, ISO13485, Canadian Medical Device Regulations, Brazil and inspection and auditing guidelines
Ability to speak, read, and write English
Good Oral and communication skills
While performing the duties of this job, the employee is regularly required to sit, talk with customer and regulatory auditors and other business contacts on the telephone frequently; therefore, the ability to hear well is essential
The employee frequently is required to read, compile, compute, and record numerical and statistical data
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.