QA Supervisor (2nd Shift)
Quality Assurance | Santa Ana, CA
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
- Must be able to lift up to 20 lbs.
For California, the base salary range for this position is $74,000 to $118,000 annually. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.).
Fujifilm is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation, and any other status protected by federal, state, or local law.
In the event that COVID-19 vaccine mandates issued by the federal government, or by state or local government become effective and enforceable, the Company will require that the successful candidate hired for positions covered under relevant government vaccine mandate(s) be fully vaccinated against COVID-19, absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption. For all positions, the Company encourages vaccination against COVID-19 and may require that the successful candidate hired be willing to test for the COVID-19 virus periodically and wear a face covering indoors absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption.
To all agencies: Please, no phone calls or emails to any employee of Fujifilm about this requisition. All resumes submitted by search firms’/employment agencies to any employee at Fujifilm via-email, the internet or in any form and/or method will be deemed the sole property of Fujifilm, unless such search firms’/employment agencies were engaged by Fujifilm for this requisition and a valid agreement with Fujifilm is in place. In the event a candidate who was submitted outside of the Fujifilm agency engagement process is hired, no fee or payment of any kind will be paid.