Quality Assurance Supervisor
We are seeking a Quality Assurance Supervisor to manage the Company's Quality Assurance personnel and activities, including: incoming QA inspection of raw materials and final products, raw material source and origin program, customer change notification, internal and supplier audit programs, deviation management and various customer and internal support as required. This position is responsible to ensure that required quality exists in all QA functions as prescribed by the FDA's GMPs (QSR), ISO 13485, MDD 93/42, IVDD 98/79/EC, Health Canada, and MDR requirements.
- 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.
- 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. Provide input as to appropriate corrective and preventive actions and suggest plans for improvement.
- Support Operation Excellence program by taking actions identified during the Quality Indicator.
- Supervise QA Inspector, QA Product Release Coordinator, and QA Change Notification Coordinator.
- 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
- Detailed knowledge of FDA's GMPs (QSR), ISO 13485, MDD 93/42, IVDD 98/79/EC, Health Canada, and MDR requirements.
- Ability to write, edit, speak and read English well.
To Apply: Please send resume with salary history to: IS_HR@irvinesci.com. Please put QAS 032417 in the subject line.
Irvine Scientific is an equal opportunity employer.
Irvine Scientific, a member of JX Holdings Group, is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. The company provides unrivalled service and quality to scientists working in cell therapy and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines. Irvine Scientific adheres to both ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA and Tokyo, Japan. The company's consultative philosophy combined with expertise in cell culture and compliance provides customers with unique capabilities and support. For over 40 years Irvine Scientific has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services. Additional information can be found at www.irvinesci.com.
Santa Ana, CA
Fri, 14 Jul 2017 14:42:08 PDT