Warehouse Quality Specialist

About the role

The Bio-Rad Irvine Distribution Center requires a dedicated Quality System Specialist to support Global Logistics operations, including regulatory compliance and the development, implementation, and continuous improvement of Quality Management System (QMS) programs.

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.
• Approve correction, containment, and communication in response to identified product performance issues.
• Promote the use of sound investigation and corrective action methods and statistical techniques.
• 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.
• Cookordination the site internal audit program.
• Primary point of contact for audits and inspections.

Requirements

• 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 implementation of QMS processes, procedures, and activities.
• Experience supervising/managing quality systems in a regulated environment.

Qualifications

• 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.

Skills

• Excellent leadership, communication, critical thinking, and organizational skills.

Benefits

At Bio-Rad, we offer a competitive and comprehensive Total Rewards Program that includes:

• Competitive medical plans for you and your family.
• Free HSA funds.
• A new fertility offering with stipend.
• Group life and disability.
• Paid parental leave.
• 401k plus profit sharing.
• An employee stock purchase program.
• A new upgraded and streamlined mental health platform.
• Extensive learning and development opportunities.
• Education benefits.
• Student debt relief program.
• Pet insurance.
• Wellness challenges and support.
• Paid time off.
• Employee Resource Groups (ERG’s).

Pay

The estimated base salary range for this position is $86,600 - $119,200 at the time of posting. Actual compensation will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors.

Schedule

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