Warehouse Quality Specialist

The Bio-Rad Irvine Distribution Center requires a dedicated Quality System Specialist to provide the leadership and direction needed to support Global Logistics operations at the facilities including regulatory compliance and the development, implementation, and continuous improvement of Quality Management System (QMS) programs compliant with all applicable regulatory requirements. This position will work across multiple functions, regions, divisions, and QMS in the business. The Quality System Specialist will be responsible for implementing, maintaining, and improving thecommecial and distribution Quality Management System and effective quality system processes, providing quality oversight, and developing and leading the Quality Assurance function, ensuring that the QMS is effective and meets customer and regulatory requirements. This individual must demonstrate excllent leadership, communication, critical thinking, and organizational skills.

Location: This position must be based in Irvine, California and requires the employee to be located within commuting distance of the office.

How You'll Make An Impact:

• Manage the ongoing collection, analysis and communication of QMS performance data.
• Communicates quality-related regulatory requirements to the organization.
• Promotes use of risk-based approaches.
• Approves correction, containment and communication in response to identified product performance issues.
• Promotes use of sound investigation and corrective action methods and statistical techniques.
• Authorizes product and process changes with moderate to high complexity or impact.
• Serves as the Quality Management Representative for the Quality Management System.
• Managing the site QMS documentation managagement process.
• Coordinaitng the site internal audit program.
• Primary point of contact for audits and inspections.

• Bachelor's degree in Engineering, Biology, Chemistry, or related discipline.
• Minimum 3-5 years relevant experience, or equivalent combination of education and experience, relevant medical device industry and quality systems experience in a regulated distribution/warehouse environment (Good Distribution Practices (GDP), ISO9001 and/or ISO 13485).
• Minimum 2 years experience working with ERP (enterprise resource planning) systems such as SAP or Oracle.
• Experience with the development and implemention of QMS processes, procedures, and activities.
• Experience supervising/managing quality systems in a regulated environment.
• Communication, public-speaking, decision-making, word processor, spreadsheet, and negotiation skils.
• Certification as an ISO9001 and/or ISO13485 lead auditor a plus.
• Audit experience (i.e. Internal, External, 3rd party).
• Strong customer orientation and focus.
• Project management, multitasking, organizational, interpersonal, and leadership skills a must.
• Ability to drive continuous improvement.