Quality Sys Spec III - Bio-Rad Laboratories : Job Details

The Bio-Rad Richmond Distribution Center requires a dedicated Quality Systems Specialist to provide the guidance 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.

How You'll Make An Impact:

The Quality System Specialist will be responsible for implementing, maintaining, and improving the commercial 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 excellent communication, critical thinking, and organizational skills.

Specific responsibilities include:

• 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 management process.
• Coordinating the site internal audit program and serving as the primary point of contact for audits and inspections.

What You Bring:

• Education: Bachelor's degree in Engineering, Biology, Chemistry, or related discipline.
• Work Experience: Minimum 3-5 years relevant experience or equivalent combination of education and experience, relevant medical device industry and quality systems experience in a regulated 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 implementation 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 skills.
• 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.