Warehouse Quality Specialist

Responsibilities

• Manage the ongoing collection, analysis, and communication of QMS performance data
• Communicate quality-related regulatory requirements to the organization
• Promote the use of risk-based approaches and sound investigation/corrective action methods
• Approve correction, containment, and communication in response to product performance issues
• Authorize product and process changes with moderate to high complexity or impact
• Serve as the Quality Management Representative for the Quality Management System
• Manage the site QMS documentation management process
• Coordinate the site internal audit program and serve as the primary point of contact for audits and inspections

Requirements

• Bachelor’s degree in Engineering, Biology, Chemistry, or a related discipline
• 3-5 years of relevant experience in the medical device industry within a regulated distribution or warehouse environment
• Experience with Good Distribution Practices (GDP), ISO 9001, and/or ISO 13485
• Minimum 2 years of experience working with ERP systems such as SAP or Oracle
• Experience with the development and implementation of QMS processes, procedures, and activities
• Proven audit experience (Internal, External, or 3rd party)
• Strong leadership, project management, and organizational skills

Preferred Qualifications

• Certification as an ISO 9001 and/or ISO 13485 lead auditor

Benefits

• Competitive medical plans for you and your family
• Free HSA funds and new fertility offering with stipend
• Group life and disability insurance
• Paid parental leave
• 401k plus profit sharing and employee stock purchase program
• Mental health platform, education benefits, and student debt relief program
• Pet insurance and wellness support
• Paid time off and Employee Resource Groups (ERGs)

About the Company

For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives.