Johnson & Johnson Careers
Staff Quality Systems Specialist
Santa Ana, California
Requisition ID: 6516190206
Johnson & Johnson Vision is recruiting for a Staff Quality Systems Specialist.
At Johnson & Johnson Vision, we have a bold ambition: to change the trajectory of eye health. That’s why, through our operating companies, we’ve developed solutions for every stage of life—to help people see better, connect better and live better. We partner with eye care professionals to provide some of the world’s leading products and technologies to address refractive error, cataracts, dry eye, and beyond. We are committed to using our reach and size for good and strive to put quality eye care within reach of everyone, everywhere. Visit us at www.jjvision.com. Follow @JNJVision on Twitter and Johnson & Johnson Vision on LinkedIn.
The Staff Quality Systems Specialist will:
• Provide overall support for the Global Quality Shipment Hold process used for the placement of product shipment holds for product that is available for sale at JJV Distribution Centers.
• Serve as a knowledge source for product distribution channels within the JJV Quality organization.
• Partner with key stakeholders including MAKE sites, Business Regional Quality and DELIVER to ensure robust and compliant processes.
• Maintain quality assurance procedures and controls, ensuring that the Global Quality Shipment Hold process is executed per company requirements.
• Management of Global Quality Shipment Hold process including execution of SAP transactions, tracking and reconciliation of product placed on hold.
• Perform quality processes including change control, non-conformance and Corrective and Preventive Action (CAPA).
• Maintain, support compliance of, and improve Global Quality Shipment Hold processes.
• Accountable, as applicable for compliance in accordance with regulations such as and from, but not limited to, FDA Quality System Regulation, ISO 13485, FDA, 21 CFR 820; and 21 CFR 210/211.
• Interact with internal and external partners.
• A minimum of a Bachelor's Degree (BS/BA) is required.
• A minimum of six (6) years of professional business experience in a regulated industry is required, preferably in Medical Device, Quality or Supply Chain.
• Understanding of the Medical Device Quality Systems, emphases on distribution controls is preferred.
• Proficiency in Microsoft Word, Power Point and Excel with competency in moderately complex functions for data analysis and trending is required.
• Working knowledge of SAP or ERP systems is required.
• Ability to learn and apply new skills quickly; highly motivated to learn and develop new processes is required.
• FDA and ISO regulations knowledge. 21 CFR 820; 21 CFR 210/211; ISO 13485; ISO 9001 is preferred.
• This position is located in Santa Ana, CA.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-California-Santa Ana-
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