Quality System Specialist III

Bio-Rad Laboratories; Irvine, California, Town of Brookhaven (CA, MO, NY); On-site; USD 84,000 - 116,000; Full time

Job summary

An established industry player is seeking a Quality System Specialist to enhance their Quality Management System (QMS) and ensure compliance with regulatory standards. This pivotal role involves collaboration across various functions and regions, focusing on continuous improvement and effective quality assurance. The ideal candidate will possess strong leadership and communication skills, alongside a robust background in quality management within regulated environments. Join a forward-thinking organization committed to advancing science and healthcare, where your contributions will have a meaningful impact on global operations.

Benefits

Comprehensive medical plans

HSA funds

Fertility benefits

Life and disability insurance

Parental leave

401k with profit sharing

Stock purchase programs

Mental health resources

Education benefits

Paid time off

Qualifications

• 3-5 years of experience in a regulated medical device environment.
• ISO 9001 and/or ISO 13485 lead auditor certification is a plus.

Responsibilities

• Manage QMS performance data collection and analysis.
• Coordinate internal audit programs and serve as primary contact for audits.
• Promote risk-based approaches in quality management.

Skills

Leadership

Communication

Critical Thinking

Organizational Skills

Quality Management Systems (QMS)

Regulatory Compliance

Risk Management

Statistical Techniques

Education

Bachelor's degree in Engineering

Bachelor's degree in Biology

Bachelor's degree in Chemistry

Tools

ERP systems (SAP, Oracle)

Job description

Bio-Rad Irvine Distribution Center - Quality System Specialist

The Bio-Rad Irvine Distribution Center is seeking a dedicated Quality System Specialist to lead and support Global Logistics operations, ensuring regulatory compliance and the development, implementation, and continuous improvement of Quality Management System (QMS) programs in accordance with applicable regulatory standards. This role involves collaboration across multiple functions, regions, divisions, and QMS processes within the organization.

The Quality System Specialist will be responsible for implementing, maintaining, and enhancing the commercial and distribution QMS, overseeing quality processes, and leading the Quality Assurance functions to ensure the effectiveness of the QMS in meeting customer and regulatory requirements. The ideal candidate will demonstrate excellent leadership, communication, critical thinking, and organizational skills.

Key Responsibilities:

1. Manage the collection, analysis, and communication of QMS performance data.
2. Communicate quality-related regulatory requirements to the organization.
3. Promote risk-based approaches in quality management.
4. Approve corrections, containment actions, and communication regarding product performance issues.
5. Encourage sound investigation and corrective action methods, including statistical techniques.
6. Authorize product and process changes with moderate to high impact or complexity.
7. Serve as the Quality Management Representative for the QMS.
8. Manage the site’s QMS documentation processes.
9. Coordinate the internal audit program and serve as the primary contact for audits and inspections.

Qualifications:

1. Bachelor's degree in Engineering, Biology, Chemistry, or related field.
2. 3-5 years of relevant experience, including experience in a regulated medical device environment (e.g., GDP, ISO 9001, ISO 13485).
3. Experience with ERP systems such as SAP or Oracle.
4. Proven experience in developing and implementing QMS processes and supervising quality systems.
5. Strong communication, decision-making, and leadership skills.
6. ISO 9001 and/or ISO 13485 lead auditor certification is a plus.
7. Audit experience (internal, external, third-party).
8. Customer-oriented mindset and ability to drive continuous improvement.

Additional Information:

We offer a comprehensive Total Rewards Package including competitive medical plans, HSA funds, fertility benefits, life and disability insurance, parental leave, 401k with profit sharing, stock purchase programs, mental health resources, learning opportunities, education benefits, student debt relief, pet insurance, wellness programs, paid time off, Employee Resource Groups, and more.

The estimated salary range is $84,300 - $116,000, with actual offers based on experience, location, and other factors. The position is eligible for an annual bonus based on individual and company performance.

About Bio-Rad:

For over 70 years, Bio-Rad has been advancing science and healthcare through innovative research and diagnostic products. As a global leader, we are committed to supporting our employees’ growth and making a positive impact worldwide.

EEO and Agency Statements:

Bio-Rad is an Equal Employment Opportunity employer. We do not accept unsolicited agency resumes unless explicitly authorized. Beware of scam attempts impersonating Bio-Rad recruiters.